Extensive-stage Small Cell Lung CancerPhase 1/2VENEZO-LUNGNCT04487756
Combination of Atezolizumab With Dendritic Cell Vaccine in Patients With Lung Cancer
A Phase 1/2 study testing Atezolizumab 1200 mg in 20 ML Injection, ADC Vaccine and Carboplatin in people with Extensive-stage Small Cell Lung Cancer, run by Instituto Oncológico Dr Rosell at 3 sites in Spain.
Trial summary
This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Atezolizumab 1200 mg in 20 ML Injection, ADC Vaccine and Carboplatin
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSpain
- Study dates
- 17 Mar 2021to 8 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of extensive-stage small cell lung cancer (ES-SCLC). Unequivocally confirmed diagnosis of SCLC by histology preferably including the presence of neuroendocrine features by immunohistochemistry.
- Centrally confirmed tumor tissue viability for vaccine preparation.
- No previous cancer treatment for advanced disease
- Life expectancy at least 16 weeks
- ECOG performance status 0 or 1.
- Adequate normal organ and marrow function as defined below:
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- Absolute neutrophil count ≥ 1.5 x 109 cells/L Platelets ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Aspartate and alanine aminotransferases (AST, ALT) ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN, if documented liver metastases are present) Total bilirubin ≤ 2 x ULN (except patients with documented Gilbert's syndrome) Creatinine < 2 mg/dl (or a glomerular filtration rate > 60)
- Prior palliative radiotherapy must have been completed at least 2 weeks prior to start the study treatment (subjects may receive localized palliative radiotherapy while receiving study drug).
- Subjects with brain metastases are eligible if they are asymptomatic, are treated, or are neurological stable for at least 2 weeks without the use of steroids, or on a stable or decreasing dose of < 10 mg daily prednisone or equivalent.
- Must be willing and able to accept one leukapheresis procedures
- Written informed consent of approved by the investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Male or female subjects aged ≥ 18 years.
- Measurable disease by RECIST.1.1 criteria.
- Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after the last atezolizumab treatment administration if the risk of conception exists.
- Negative serum pregnancy test at screening for women of childbearing potential. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- Central negative serologic determination to HBsAg, Anti-HBc, HBV, HCV, HCV RNA, HIV-I RNA, Agp24 IIIV + AC IIIV ½ (MLIA) serum, IgG antigen core v. hepatitis B, RPR (Ac reaginic Lues-RPR, serum), Ac anti-HTLV I/II (if the patient came from an endemic zone), Ac anti-Trypanosoma Cruzi, Chagas, (if a patient came from the endemic zone), when RPR positive or doubtful for confirmation: IgG T. pallidum (ELISA) immunoglobulin M (IgM) T. pallidum (ELISA), when IgG T. Pallidum doubtful: Pt confirmatory immunoglobulin G (IgG)/IGM, T pallidum (LIA).
Who cannot join
- Prior chemotherapy for extensive-stage ES-SCLC
- Any prior anti-PD-1/PD-L1 antibody therapy
- History of, or significant evidence of risk for, severe chronic inflammatory or autoimmune disease
- Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment (inhaled or topical steroids at standard doses are allowed)
- Human immunodeficiency virus (HIV) seropositivity, active Hepatitis B or C seropositivity
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
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- Pregnancy or breastfeeding; female patients must be surgically sterile or be postmenopausal for two years or must agree to use effective contraception during the period of treatment and 6 months after; all female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 24 hours from starting the conditioning chemotherapy; the definition of effective contraception will be based on the judgment of the study investigators; patients who are breastfeeding are not allowed on study
- Any unresolved toxicity (CTCAE grade 2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy).
- Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. For phase I cohort, patients with autoimmune paraneoplastic syndromes will be also excluded.
- Any syndrome that requires systemic corticosteroid/immunosuppressive medication EXCEPT for syndromes which would not be expected to recur in the absence of an external trigger (vitiligo, autoimmune thyroiditis, or type 1 diabetes mellitus are permitted to enroll)
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- History of primary immunodeficiency.
- History of allogeneic organ transplant. 14 History of hypersensitivity to atezolizumab / ADC vaccine or any excipient.
- 15- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diathesis including any subject known to have evidence of acute or chronic hepatitis B or C or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
- 16- Known history of active tuberculosis. 17- Subjects with previous malignancies (except for non-melanoma skin cancer, and cancer in situ of the bladder, gastric, colon, cervical/dysplasia, melanoma, breast) are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
- 18- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving atezolizumab.
- 19- Prior allogeneic stem-cell transplantation. 20- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v 5.0), any history of anaphylaxis, or uncontrolled asthma.
- 21- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 180 days after the last dose of ADC + atezolizumab combination therapy.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
ICO Badalona
Badalona, Barcelona, 08916
Quirón Dexeus
Barcelona, Barcelona, 08028
Hospital Clínic Barcelona
Barcelona, Barcelona, 08036
About this study
Official title: Phase Ib/II Trial of the Combination of Atezolizumab With Dendritic Cell Vaccination as Maintenance Treatment in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) After Induction Treatment
This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study.
Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab for four 21-day cycles (induction phase), followed by a maintenance phase during which they will receive the dendritic cell vaccine (6 doses maximum) in combination with atezolizumab until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit.
Read more
The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both in the intention-to-treat population. Secondary Outcome Measures include: Duration of clinical benefit (DCB), Overall survival (OS) and Overall response rate (ORR)
The translational substudy will include:
Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA expression, Work Environmental Scale (WES) analysis, and flow cytometry in pretreatment fresh tumor tissue.
The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis
Read the detailed description
This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study.
Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab for four 21-day cycles (induction phase), followed by a maintenance phase during which they will receive atezolizumab and dendritic cell vaccine combination until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit. The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both in the intention-to-treat population.
In the Phase Ib safety lead-in portion, up to 6 patients will be enrolled into and evaluated for dose-limiting toxicities (DLT) during the first 2 cycles of the maintenance therapy. If <2 out of 6 patients present with limiting toxicities, the administration of the investigational products will be deemed safe in the Phase 1b lead-in, therefore enrollment will be expanded into the Phase 2 cohort. Inclusion and treatment of up to 20 patients (including those enrolled in the Phase Ib lead-in) with atezolizumab and dendritic cell vaccination as maintenance therapy is finally expected.
Safety assessments will be based on adverse event reports, results of clinical laboratory tests, immune safety tests, physical examinations, vital sign measurements, Eastern Cooperative Oncology Group (ECOG) performance status both during the study, and up to six months following the last study drug administration. Adverse events (AEs) will be assessed throughout the study period and evaluated by using National Cancer Institute (NCI) Common Technology Criteria version of Adverse Events version 5.0 (NCI CTCAE v 5.0).
Tumor measurements will be performed by computed tomography (CT) scan at baseline, at week 6 (W6), at week 12 (W12), and every 9 weeks thereafter, to evaluate 6m PFS and response to treatment. The response will be evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the immune-related response criteria (irRECIST) as a secondary endpoint. Brain magnetic resonance imaging (MRI) will be performed at baseline (mandatory as per clinical practice), and along with CT scan at each timepoint, if there are brain metastasis at baseline.
Patients with stable disease (SD), partial response (PR) or complete response (CR) after induction with chemotherapy plus atezolizumab (CT scan on W12) will continue during the maintenance phase with atezolizumab plus dendritic cell vaccine.
Treatment with atezolizumab will continue until disease progression (PD), significant clinical deterioration, unacceptable toxicity, or if any criteria for withdrawal from the trial is fulfilled.
Treatment with dendritic cell vaccines will continue for a maximum of 6 doses until PD, significant clinical deterioration, unacceptable toxicity, or if any criteria for withdrawal from the trial are fulfilled (whichever occurs first).
Treatment may continue after the initial determination of PD per RECIST 1.1 if the subject's performance status remains stable, and if the opinion of the principal investigator, the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol.
For patients who have a confirmed CR or PR, it should be considered prophylactic cranial irradiation (PCI) after completion of chemotherapy (i.e., induction) based on the investigator's judgment. Following the completion of the induction part, PCI may be administered concurrently with atezolizumab and dendritic cell vaccination during the maintenance part. For those patients who have not progressed at the time of study drug discontinuation, the tumor assessments (including all disease locations) will be assessed radiologically by CT or MRI, as performed at screening, every 9 weeks (approximately 63 ± 7 days), until the occurrence of PD or study completion. The same method of assessment (CT or MRI) should be used to characterize tumors at screening and at all follow-up assessments. If positron emission tomography (PET) is used, it should also be accompanied by spiral CT or MRI.
Safety will be defined based on the rate of serious adverse events (SAEs) comparing with historic controls of atezolizumab in monotherapy as a maintenance treatment.
Kaplan Meier method will be used to estimate the survival function. Translational study
Tumor samples: All patients will undergo baseline tumor tissue acquisition prior to enrollment. The only mandatory tissue biopsy is pretreatment. Tissue samples:
Pre induction treatment fresh and paraffin-embedded tumor sample (If obtaining a fresh biopsy is not feasible, the case should be discussed with Coordinating Investigators) Pre maintenance phase (for those that rebiopsy is feasible) After 24 weeks on maintenance phase (for those patents that continue on treatment after w24 on maintenance and rebiopsy is feasible) At tumor progression (for those patients who progressed and rebiopsy is feasible).
Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA expression, WES analysis, and flow cytometry in pretreatment fresh tumor tissue.
Peripheral blood samples: Peripheral blood samples will be collected:
Pre induction treatment Pre maintenance phase After 9 weeks of the first vaccination At progression of the disease The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Atezolizumab 1200 mg in 20 ML Injection, ADC Vaccine, Carboplatin
- Keywords
- Small cell lung cancer, Atezolizumab, Dendritic cell vaccine, Safety, Efficacy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab 1200 mg in 20 ML InjectionDrug
Also called Tecentriq
- Induction (4 cycles, every 3 weeks): Atezolizumab, 1200 mg administered intravenously every 3 weeks on day 1 of each cycle)
- Maintenance (only patients without PD after 4 induction cycles, up to PD): Atezolizumab iv (1200 mg/IV on day 1 every 3 weeks)
ADC VaccineBiological
Also called Autologous Dendritic cell (ADC) vaccine, Dendritic cell (DC) vaccine
- Maintenance (only patients without PD after 4 induction cycles, up to PD): DCV intradermally (max. 6 doses) on weeks 1, 3, 6, 9, 21, 33.
CarboplatinDrug
Also called Carboplatino (Teva/Accord/Pharmacia)
- Induction (4 cycles, every 3 weeks): Carboplatin AUC 5 (5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle)
| Study group | Role | What they receive |
|---|---|---|
| Atezo+DCvac | Experimental | - Induction (4 cycles, every 3 weeks): Carboplatin area under the curve (AUC) 5 (5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle) Atezolizumab, 1200 mg administered intravenously every 3 weeks on day 1 of each cycle)
- Maintenance (only patients without PD after 4 induction cycles, up to PD): Atezolizumab iv (1200 mg/IV on day 1 every 3 weeks) DCV intradermally (max. 6 doses) on weeks 1, 3, 6, 9, 21, 33. Receives: Drug: Atezolizumab 1200 mg in 20 ML Injection; Biological: ADC Vaccine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) rate at 6 months
Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1
Measured: At 6 months after start of treatment
Frequency and severity of AEs and SAEs (Safety)
he number of patients with AEs and SAEs, changes in laboratory values, vital signs, ECGs, and results of physician examinations graded according to the CTCAE v 5.0.
Measured: Throughout the study. Approximately 3 years
Secondary outcomes (4)
Duration of clinical benefit (DCB) as per RECIST 1.1
DCB calculated as the time (in months) from first dose of treatment to progression (or death from any cause) in patients who had a best overall response of CR, PR, or SD of ≥ 24 weeks.
Measured: Throughout the study. Approximately 3 years
Overall Survival (OS)
Median Overall Survival (mOS) is calculated as the time from date of inclusion to date of death due to any cause.
Measured: Throughout the study. Approximately 3 years
Objective response rate (ORR1) as per RECIST 1.1
Rate of patients that achieve partial or complete response as best response during study induction treatment
Measured: Throughout the study. Approximately 3 years
Objective response rate (ORR2) as per RECIST 1.1
Rate of patients that have a further best response during maintenance treatment
Measured: Throughout the study. Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start17 Mar 2021
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm Phase Ib/II multicenter open label study, with translational sub-study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Oncológico Dr Rosell
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Sponsor
- Investigators
- María González Cao, Study chair, Hospital Quirón-Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487756
- Sponsor's protocol ID
- IOR-IISML42037
- Other IDs
- 2020-000448-72
- Acronym
- VENEZO-LUNG
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2020
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Cao M, Sistere-Oro M, Moran T, Reguart N, Cabezon R, Aguilar Hernandez A, Roman R, Molina-Vila MA, Birgin K, Domenjo-Vila E, Pique G, Lozano M, Charry P, Reyes R, Moya I, Cirera L, Esparre C, Drozdowskyj A, Martinez Perez E, Rosell R, Juan M, Meyerhans A, Benitez-Ribas D. Personalized tumor-loaded monocyte-derived dendritic cell vaccination in combination with atezolizumab as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC): phase Ib-II VENEZOLUNG trial. J Immunother Cancer. 2026 Jul 24;14(7):e015351. doi: 10.1136/jitc-2026-015351.
PubMed 42498486
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Trial of the Combination of Atezolizumab With Dendritic Cell Vaccination as Maintenance Treatment in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) After Induction Treatment
- ClinicalTrials.gov ID
- NCT04487756
- Acronym / sponsor ID
- VENEZO-LUNG / IOR-IISML42037
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- Small cell lung cancer, Atezolizumab, Dendritic cell vaccine, Safety, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Oncológico Dr RosellUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Fundacion Clinic per a la Recerca Biomédica
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study.
Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab for four 21-day cycles (induction phase), followed by a maintenance phase during which they will receive the dendritic cell vaccine (6 doses maximum) in combination with atezolizumab until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit.
The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both in the intention-to-treat population. Secondary Outcome Measures include: Duration of clinical benefit (DCB), Overall survival (OS) and Overall response rate (ORR)
The translational substudy will include:
Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA expression, Work Environmental Scale (WES) analysis, and flow cytometry in pretreatment fresh tumor tissue.
The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis
Detailed description
This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study.
Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab for four 21-day cycles (induction phase), followed by a maintenance phase during which they will receive atezolizumab and dendritic cell vaccine combination until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit. The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both in the intention-to-treat population.
In the Phase Ib safety lead-in portion, up to 6 patients will be enrolled into and evaluated for dose-limiting toxicities (DLT) during the first 2 cycles of the maintenance therapy. If <2 out of 6 patients present with limiting toxicities, the administration of the investigational products will be deemed safe in the Phase 1b lead-in, therefore enrollment will be expanded into the Phase 2 cohort. Inclusion and treatment of up to 20 patients (including those enrolled in the Phase Ib lead-in) with atezolizumab and dendritic cell vaccination as maintenance therapy is finally expected.
Safety assessments will be based on adverse event reports, results of clinical laboratory tests, immune safety tests, physical examinations, vital sign measurements, Eastern Cooperative Oncology Group (ECOG) performance status both during the study, and up to six months following the last study drug administration. Adverse events (AEs) will be assessed throughout the study period and evaluated by using National Cancer Institute (NCI) Common Technology Criteria version of Adverse Events version 5.0 (NCI CTCAE v 5.0).
Tumor measurements will be performed by computed tomography (CT) scan at baseline, at week 6 (W6), at week 12 (W12), and every 9 weeks thereafter, to evaluate 6m PFS and response to treatment. The response will be evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the immune-related response criteria (irRECIST) as a secondary endpoint. Brain magnetic resonance imaging (MRI) will be performed at baseline (mandatory as per clinical practice), and along with CT scan at each timepoint, if there are brain metastasis at baseline.
Patients with stable disease (SD), partial response (PR) or complete response (CR) after induction with chemotherapy plus atezolizumab (CT scan on W12) will continue during the maintenance phase with atezolizumab plus dendritic cell vaccine.
Treatment with atezolizumab will continue until disease progression (PD), significant clinical deterioration, unacceptable toxicity, or if any criteria for withdrawal from the trial is fulfilled.
Treatment with dendritic cell vaccines will continue for a maximum of 6 doses until PD, significant clinical deterioration, unacceptable toxicity, or if any criteria for withdrawal from the trial are fulfilled (whichever occurs first).
Treatment may continue after the initial determination of PD per RECIST 1.1 if the subject's performance status remains stable, and if the opinion of the principal investigator, the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol.
For patients who have a confirmed CR or PR, it should be considered prophylactic cranial irradiation (PCI) after completion of chemotherapy (i.e., induction) based on the investigator's judgment. Following the completion of the induction part, PCI may be administered concurrently with atezolizumab and dendritic cell vaccination during the maintenance part. For those patients who have not progressed at the time of study drug discontinuation, the tumor assessments (including all disease locations) will be assessed radiologically by CT or MRI, as performed at screening, every 9 weeks (approximately 63 ± 7 days), until the occurrence of PD or study completion. The same method of assessment (CT or MRI) should be used to characterize tumors at screening and at all follow-up assessments. If positron emission tomography (PET) is used, it should also be accompanied by spiral CT or MRI.
Safety will be defined based on the rate of serious adverse events (SAEs) comparing with historic controls of atezolizumab in monotherapy as a maintenance treatment.
Kaplan Meier method will be used to estimate the survival function. Translational study
Tumor samples: All patients will undergo baseline tumor tissue acquisition prior to enrollment. The only mandatory tissue biopsy is pretreatment. Tissue samples:
Pre induction treatment fresh and paraffin-embedded tumor sample (If obtaining a fresh biopsy is not feasible, the case should be discussed with Coordinating Investigators) Pre maintenance phase (for those that rebiopsy is feasible) After 24 weeks on maintenance phase (for those patents that continue on treatment after w24 on maintenance and rebiopsy is feasible) At tumor progression (for those patients who progressed and rebiopsy is feasible).
Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA expression, WES analysis, and flow cytometry in pretreatment fresh tumor tissue.
Peripheral blood samples: Peripheral blood samples will be collected:
Pre induction treatment Pre maintenance phase After 9 weeks of the first vaccination At progression of the disease The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm Phase Ib/II multicenter open label study, with translational sub-study
| Arm | Type | Receives |
|---|---|---|
| Atezo+DCvac | Experimental | Drug: Atezolizumab 1200 mg in 20 ML Injection, Biological: ADC Vaccine, Drug: Carboplatin- Induction (4 cycles, every 3 weeks): Carboplatin area under the curve (AUC) 5 (5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle) Atezolizumab, 1200 mg administered intravenously every 3 weeks on day 1 of each cycle) - Maintenance (only patients without PD after 4 induction cycles, up to PD): Atezolizumab iv (1200 mg/IV on day 1 every 3 weeks) DCV intradermally (max. 6 doses) on weeks 1, 3, 6, 9, 21, 33. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histological diagnosis of extensive-stage small cell lung cancer (ES-SCLC). Unequivocally confirmed diagnosis of SCLC by histology preferably including the presence of neuroendocrine features by immunohistochemistry.
- Centrally confirmed tumor tissue viability for vaccine preparation.
- No previous cancer treatment for advanced disease
- Life expectancy at least 16 weeks
- ECOG performance status 0 or 1.
Key exclusion criteria (18 listed)
- Prior chemotherapy for extensive-stage ES-SCLC
- Any prior anti-PD-1/PD-L1 antibody therapy
- History of, or significant evidence of risk for, severe chronic inflammatory or autoimmune disease
- Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 2 weeks prior to enrollment (inhaled or topical steroids at standard doses are allowed)
- Human immunodeficiency virus (HIV) seropositivity, active Hepatitis B or C seropositivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab 1200 mg in 20 ML InjectionAlso: Tecentriq- Induction (4 cycles, every 3 weeks): Atezolizumab, 1200 mg administered intravenously every 3 weeks on day 1 of each cycle) - Maintenance (only patients without PD after 4 induction cycles, up to PD): Atezolizumab iv (1200 mg/IV on day 1 every 3 weeks) | Drug | Atezo+DCvac |
| ADC VaccineAlso: Autologous Dendritic cell (ADC) vaccine, Dendritic cell (DC) vaccine- Maintenance (only patients without PD after 4 induction cycles, up to PD): DCV intradermally (max. 6 doses) on weeks 1, 3, 6, 9, 21, 33. | Biological | Atezo+DCvac |
| CarboplatinAlso: Carboplatino (Teva/Accord/Pharmacia)- Induction (4 cycles, every 3 weeks): Carboplatin AUC 5 (5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle) | Drug | Atezo+DCvac |
Primary outcome
Progression-Free Survival (PFS) rate at 6 months
Time frame: At 6 months after start of treatment
Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1
Frequency and severity of AEs and SAEs (Safety)
Time frame: Throughout the study. Approximately 3 years
he number of patients with AEs and SAEs, changes in laboratory values, vital signs, ECGs, and results of physician examinations graded according to the CTCAE v 5.0.
4 secondary outcomes
Duration of clinical benefit (DCB) as per RECIST 1.1
Time frame: Throughout the study. Approximately 3 years
Overall Survival (OS)
Time frame: Throughout the study. Approximately 3 years
Objective response rate (ORR1) as per RECIST 1.1
Time frame: Throughout the study. Approximately 3 years
Objective response rate (ORR2) as per RECIST 1.1
Time frame: Throughout the study. Approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 42498486Gonzalez-Cao M, Sistere-Oro M, Moran T, Reguart N, Cabezon R, Aguilar Hernandez A, Roman R, Molina-Vila MA, Birgin K, Domenjo-Vila E, Pique G, Lozano M, Charry P, Reyes R, Moya I, Cirera L, Esparre C, Drozdowskyj A, Martinez Perez E, Rosell R, Juan M, Meyerhans A, Benitez-Ribas D. Personalized tumor-loaded monocyte-derived dendritic cell vaccination in combination with atezolizumab as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC): phase Ib-II VENEZOLUNG trial. J Immunother Cancer. 2026 Jul 24;14(7):e015351. doi: 10.1136/jitc-2026-015351.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María González Cao study chair
Hospital Quirón-Dexeus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atezolizumab 1200 mg in 20 ML Injection, ADC Vaccine and Carboplatin in people with Extensive-stage Small Cell Lung Cancer, run by Instituto Oncológico Dr Rosell at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) rate at 6 months (time frame: At 6 months after start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.