Small Cell Lung CarcinomaPhase 2FASTIMMUNENCT05703997
FASTing-like Approach and Maintenance IMMunotherapy in ES-SCLC Patients Not Progressing on Chemoimmunotherapy Induction
A Phase 2 study testing Cyclic, 5-day calorie restriction and Atezolizumab in people with Small Cell Lung Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Cyclic, 5-day calorie restriction is a safe metabolic intervention when combined with standard therapies in cancer patients, favorably reshaping peripheral blood and intratumor metabolism and immunity in a way that may improve the antitumor activity and efficacy of immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Cyclic, 5-day calorie restriction and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2023to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are able to comply with the requirements and restrictions listed in the Informed Consent Form and the study protocol (there is no separate Informed Consent Form for entering the maintenance phase)
- Signature of the informed consent form for those patients who have not previously participated to the induction phase of the study
- Age greater than or equal to 18 years and less than or equal to 75 years
- Willingness and ability to comply with the prescribed cyclic, 5-day calorie restriction regimen, the scheduled visits, treatment plans, laboratory tests and other procedures
- Histologically or cytologically confirmed diagnosis of small-cell lung cancer (SCLC).
- Radiological evidence of extensive-stage (ES) disease.
Show all 18Show fewer
- Patient has available archival tumor tissue. Patients for whom only cytological material is available may be enrolled only if cytoincluded material is available.
- Patients must have received a first-line, chemoimmunotherapy induction with 4 triweekly cycles of atezolizumab plus carboplatin and etoposide, with the last cycle of induction chemoimmunotherapy administered not more than six weeks before the initiation of experimental maintenance treatment. Delays between cycles of chemoimmunotherapy due to the occurrence of AEs or other medical reasons are considered acceptable, provided that a total number of 4 cycles of chemoimmunotherapy with atezolizumab plus carboplatin and etoposide have been administered, and that there is no radiological evidence of disease progression.
- Radiological evidence of nonprogressive disease after chemoimmunotherapy induction with 4 triweekly cycles of atezolizumab plus carboplatin and etoposide.
- Patients with a history of treated CNS metastases are eligible, if there is no evidence of interim progression between the completion of CNS-directed therapy and the experimental maintenance treatment initiation, and if CNS metastases are asymptomatic.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Presence of an adequate bone marrow and organ function
- Female patients of childbearing potential must agree to abstinence from heterosexual intercourse or to use two highly effective methods of contraception throughout the study and for at least six months after the end of the maintenance treatment.
- Female patients are not of childbearing potential if they meet at least one of the following criteria:
- Have undergone a documented hysterectomy and/or bilateral oophorectomy
- Have medically confirmed ovarian failure
- Achieved post-menopausal status
- Male patients must agree to abstinence from heterosexual intercourse or to use two highly effective methods of contraception during sexual contact with a female with childbearing potential throughout the study and for at least six months after the end of the maintenance treatment.
Who cannot join
- Prior systemic treatment for ES SCLC, with the exception for first-line chemoimmunotherapy induction with 4 triweekly cycles of atezolizumab plus carboplatin and etoposide. Patients who received prior concurrent chemoradiotherapy for limited-stage (LS) disease may be enrolled if concurrent chemoradiotherapy was concluded at least three months before enrollment.
- Patient has not available archival tumor tissue or has only cytological material without cytoincluded material available.
- The patient has not recovered from immune-related AEs of grade 2 or higher from the induction phase with atezolizumab plus carboplatin and etoposide. Patients with adequately-treated, controlled, immune-related skin rash of grade 2 or adequately-treated, controlled, endocrinopathies of grade 2 on replacement therapy can be enrolled.
- Body mass index (BMI) < 19 kg/m2.
- Unintentional weight loss ≥ 5% in the previous 3 months, unless the patient has a BMI > 22 kg/m2 and weight loss has been lower than 10% at the time of enrollment in the study; or unintentional weight loss ≥ 10% in the previous 3 months, unless the patient has a BMI > 25 kg/m2 and weight loss has been lower than 15% at the time of the enrollment in the study. In all cases, weight must have been stable for at least one month before study enrollment.
- Baseline plasma glucose concentration ≤ 60 mg/dL (after at least 8 hours fasting)
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- Diagnosis of any other malignancy within 2 years prior to enrollment, with the exception of adequately treated in-situ bladder cancer, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, ductal in-situ breast cancer, thyroid cancer or early-stage prostate cancer (all treatment of which should have been completed at least 6 months prior to enrollment)
- Asymptomatic and untreated, symptomatic or unstable CNS metastases as determined by CT-scan or MRI evaluation during screening and/or prior radiographic assessments.
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated but not clinically stable for ≥ 4 weeks prior to the experimental maintenance treatment initiation.
- Leptomeningeal disease.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- History of alcohol abuse.
- Active pregnancy or breastfeeding.
- Known active B or C hepatitis or human immunodeficiency virus (HIV) infection, or occasional finding of active hepatitis B/C infection during screening tests before experimental treatment initiation.
- Serious infections in the previous 4 weeks before the experimental maintenance treatment initiation.
- Active autoimmune diseases requiring systemic treatments (e.g., systemic steroids or immunosuppressants).
- Other medical conditions requiring active chronic therapy with systemic steroids at a dose ≥ 10 mg per day of prednisone or equivalent or other immunosuppressive medications within 14 days before the experimental maintenance treatment initiation.
- Adrenal replacement steroid doses ≥ 10 mg per day of prednisone or equivalent are permitted in the absence of active autoimmune disease
- Diagnosis of type 1 or 2 diabetes mellitus requiring pharmacologic therapy (including, but not limited to, insulin and secretagogues). A diagnosis of type 2 diabetes mellitus not requiring insulin and secretagogues on the judgment of a diabetologist and treated with metformin or alpha-glucosidase inhibitors (e.g., acarbose) is compatible with patient enrollment in the trial.
- Active gastric or intestinal ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small intestine resection.
- Anamnesis of clinically significant heart disease including:
- angina pectoris, coronary bypass, symptomatic pericarditis, myocardial infarction in the previous 12 months from the beginning of experimental maintenance treatment.
- congestive heart failure NYHA class III-IV.
- cardiac arrhythmias, such as ventricular tachycardia, chronic atrial fibrillation, complete bundle branch block, high grade atrio-ventricular block like bi-fascicular block, type II Mobitz and third grade atrio-ventricular block, nodal arrhythmias, supra-ventricular arrhythmias.
- Previous episodes of symptomatic hypotension leading to loss of consciousness.
- Medical or psychiatric comorbidities rendering the patient not candidate to the clinical trial, according to the investigator's judgement.
- Other cardiac, liver, lung or renal comorbidities, not specified in the previous inclusion or exclusion criteria, but potentially exposing the patient to a high risk of lactic acidosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FASTing-like Approach to Improve the Efficacy of Maintenance IMMunotherapy in Extensive-stage Small Cell Lung Cancer Patients Not Progressing on Chemoimmunotherapy Induction: the FASTIMMUNE Trial
Cyclic, 5-day calorie restriction is a safe metabolic intervention when combined with standard therapies in cancer patients, favorably reshaping peripheral blood and intratumor metabolism and immunity in a way that may improve the antitumor activity and efficacy of immunotherapy.
The goal of this clinical trial is to test if combining cyclic, 5-day calorie restriction with atezolizumab maintenance in patients with ES SCLC achieving at least stable disease after four cycles of induction atezolizumab plus carboplatin and etoposide chemoimmunotherapy may increase the efficacy of a standard first-line, chemo-immunotherapy approach in terms of patient PFS.
Read more
The main question it aims to answer is:
- does the combination of cyclic, 5-day calorie restriction with triweekly atezolizumab increase the 6 months PFS rate, as evaluated from maintenance treatment initiation, compared to historical results with standard atezolizumab maintenance monotherapy in patients with ES SCLC non-progressive after four cycles of first-line chemo-immunotherapy induction with atezolizumab plus carboplatin and etoposide?
Read the detailed description
SCLC is the most aggressive and deadly subtype of lung cancer. Indeed, despite the novel treatment strategies, patients with ES SCLC still have a dismal prognosis. The most relevant therapeutic progress that occurred in the last decades in the treatment of this disease consists in the combination of immunotherapy (anti PD-L1 monoclonal antibodies) with standard cytotoxic chemotherapy as the first-line treatment. However, in clinical trials that led to the registration of currently used chemoimmunotherapy combination regimens, the addition of immunotherapy to chemotherapy approaches only led to a marginal increase in patient PFS and OS. Therefore, novel therapeutic strategies are needed to increase the efficacy of chemo-immunotherapy approaches. Pre-clinical and translational evidence suggests that patients with ES SCLC receiving anti-PD-1/PD-L1 agents may benefit from the combination of cyclic, short-term calorie restriction to immunotherapy both for reasons related to the metabolic vulnerabilities of SCLC cells (e.g., enhanced glycolysis) and their potential sensitivity to glucose-lowering strategies, and to the potential synergistic antitumor effects resulting from the combination of immunotherapy with cyclic calorie restriction. Based on these data, we design the FASTIMMUNE trial, a single center, open-label, single arm, phase II clinical study with a Simon's two-stage design. The study consists of 2 phases: an induction phase and an experimental maintenance treatment phase. Participants will undergo an experimental maintenance treatment with triweekly cycles of 5-day calorie restriction (on days -2 through 2 of each cycle) in combination with atezolizumab (at a dose of 1200 mg, administered intravenously on day 0 of each cycle) until the occurrence of unacceptable toxic effects, disease progression, consent withdrawal or patient death. Patients interrupting cyclic calorie restriction for any reason other than disease progression may continue the maintenance treatment with atezolizumab alone, if clinically indicated.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Cyclic, 5-day calorie restriction, Atezolizumab
- Keywords
- Small Cell Lung Cancer, SCLC, Extensive-stage, Calorie-restriction, Immunotherapy
- 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.
Cyclic, 5-day calorie restrictionDietary supplement
Cyclic, 5-day, calorie-restricted (about 600 Kcal on day 1; about 300 Kcal on days 2 to 5), plant-based, low-protein, low-carbohydrate diet.
AtezolizumabDrug
Atezolizumab 1200 mg administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance treatment with cyclic, 5-day calorie restriction plus atezolizumab | Experimental | The experimental maintenance treatment will consist of:
* triweekly cycles of 5-day calorie restriction (on days -2 through 2 of each cycle) in combination with
* atezolizumab (at a dose of 1200 mg, administered intravenously on day 0 of each cycle)
The experimental maintenance treatment will be administered until the occurrence of unacceptable toxic effects, disease progression, consent withdrawal or patient death.
Patients interrupting cyclic calorie restriction for any reason other than disease progression may continue the maintenance treatment with atezolizumab alone, if clinically indicated. Receives: Dietary Supplement: Cyclic, 5-day calorie restriction; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS rate at 6 months
The percentage of patients not experiencing disease progression or death from any cause after 6 months from experimental maintenance treatment initiation
Measured: 6 months from experimental maintenance treatment initiation
Secondary outcomes (4)
PFS
The time between experimental maintenance treatment initiation and the date of disease progression or death from any cause
Measured: Up to 75 months from experimental maintenance treatment initiation
OS
The time between experimental maintenance treatment initiation and the date of patient death from any cause
Measured: Up to 75 months from experimental maintenance treatment initiation
Compliance
Percentage of patients undergoing minor and major deviations to the experimental dietary regimen; percentage of premature treatment withdrawals
Measured: Up to 75 months from experimental maintenance treatment initiation
Adverse events
Incidence, severity, seriousness and correlation to experimental dietary regimen/maintenance atezolizumab treatment of AEs, according of NCI-CTCAE, version 5.0; maximum toxicity grade experienced by each patient for each specific toxicity; percentage of patients experiencing grade 3-4 toxicity for each specific toxicity; patients with at least one SAE
Measured: Up to 75 months from experimental maintenance treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- IFOM ETS - The AIRC Institute of Molecular Oncology, University of Milan
- Responsible party
- Sponsor
- Investigators
- Filippo de Braud, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703997
- Sponsor's protocol ID
- INT 207/22
- Acronym
- FASTIMMUNE
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. Nat Rev Dis Primers. 2021 Jan 14;7(1):3. doi: 10.1038/s41572-020-00235-0.
PubMed 33446664Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
PubMed 30280641Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.
PubMed 33439693Ajona D, Ortiz-Espinosa S, Lozano T, Exposito F, Calvo A, Valencia K, Redrado M, Remirez A, Lecanda F, Alignani D, Lasarte JJ, Macaya I, Senent Y, Bertolo C, Sainz C, Gil-Bazo I, Eguren-Santamaria I, Lopez-Picazo JM, Gonzalez A, Perez-Gracia JL, de Andrea CE, Vicent S, Sanmamed MF, Montuenga LM, Pio R. Short-term starvation reduces IGF-1 levels to sensitize lung tumors to PD-1 immune checkpoint blockade. Nat Cancer. 2020 Jan;1(1):75-85. doi: 10.1038/s43018-019-0007-9. Epub 2020 Jan 13.
PubMed 35121837Vernieri C, Fuca G, Ligorio F, Huber V, Vingiani A, Iannelli F, Raimondi A, Rinchai D, Frige G, Belfiore A, Lalli L, Chiodoni C, Cancila V, Zanardi F, Ajazi A, Cortellino S, Vallacchi V, Squarcina P, Cova A, Pesce S, Frati P, Mall R, Corsetto PA, Rizzo AM, Ferraris C, Folli S, Garassino MC, Capri G, Bianchi G, Colombo MP, Minucci S, Foiani M, Longo VD, Apolone G, Torri V, Pruneri G, Bedognetti D, Rivoltini L, de Braud F. Fasting-Mimicking Diet Is Safe and Reshapes Metabolism and Antitumor Immunity in Patients with Cancer. Cancer Discov. 2022 Jan;12(1):90-107. doi: 10.1158/2159-8290.CD-21-0030. Epub 2021 Nov 17.
PubMed 34789537Ligorio F, Fuca G, Provenzano L, Lobefaro R, Zanenga L, Vingiani A, Belfiore A, Lorenzoni A, Alessi A, Pruneri G, de Braud F, Vernieri C. Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. Eur J Cancer. 2022 Sep;172:300-310. doi: 10.1016/j.ejca.2022.05.046. Epub 2022 Jul 8.
PubMed 35810555
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FASTing-like Approach to Improve the Efficacy of Maintenance IMMunotherapy in Extensive-stage Small Cell Lung Cancer Patients Not Progressing on Chemoimmunotherapy Induction: the FASTIMMUNE Trial
- ClinicalTrials.gov ID
- NCT05703997
- Acronym / sponsor ID
- FASTIMMUNE / INT 207/22
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Small Cell Lung Cancer, SCLC, Extensive-stage, Calorie-restriction, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- IFOM ETS - The AIRC Institute of Molecular Oncology, University of Milan
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 30 Jan 2023 (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.
Cyclic, 5-day calorie restriction is a safe metabolic intervention when combined with standard therapies in cancer patients, favorably reshaping peripheral blood and intratumor metabolism and immunity in a way that may improve the antitumor activity and efficacy of immunotherapy.
The goal of this clinical trial is to test if combining cyclic, 5-day calorie restriction with atezolizumab maintenance in patients with ES SCLC achieving at least stable disease after four cycles of induction atezolizumab plus carboplatin and etoposide chemoimmunotherapy may increase the efficacy of a standard first-line, chemo-immunotherapy approach in terms of patient PFS.
The main question it aims to answer is:
- does the combination of cyclic, 5-day calorie restriction with triweekly atezolizumab increase the 6 months PFS rate, as evaluated from maintenance treatment initiation, compared to historical results with standard atezolizumab maintenance monotherapy in patients with ES SCLC non-progressive after four cycles of first-line chemo-immunotherapy induction with atezolizumab plus carboplatin and etoposide?
Detailed description
SCLC is the most aggressive and deadly subtype of lung cancer. Indeed, despite the novel treatment strategies, patients with ES SCLC still have a dismal prognosis. The most relevant therapeutic progress that occurred in the last decades in the treatment of this disease consists in the combination of immunotherapy (anti PD-L1 monoclonal antibodies) with standard cytotoxic chemotherapy as the first-line treatment. However, in clinical trials that led to the registration of currently used chemoimmunotherapy combination regimens, the addition of immunotherapy to chemotherapy approaches only led to a marginal increase in patient PFS and OS. Therefore, novel therapeutic strategies are needed to increase the efficacy of chemo-immunotherapy approaches. Pre-clinical and translational evidence suggests that patients with ES SCLC receiving anti-PD-1/PD-L1 agents may benefit from the combination of cyclic, short-term calorie restriction to immunotherapy both for reasons related to the metabolic vulnerabilities of SCLC cells (e.g., enhanced glycolysis) and their potential sensitivity to glucose-lowering strategies, and to the potential synergistic antitumor effects resulting from the combination of immunotherapy with cyclic calorie restriction. Based on these data, we design the FASTIMMUNE trial, a single center, open-label, single arm, phase II clinical study with a Simon's two-stage design. The study consists of 2 phases: an induction phase and an experimental maintenance treatment phase. Participants will undergo an experimental maintenance treatment with triweekly cycles of 5-day calorie restriction (on days -2 through 2 of each cycle) in combination with atezolizumab (at a dose of 1200 mg, administered intravenously on day 0 of each cycle) until the occurrence of unacceptable toxic effects, disease progression, consent withdrawal or patient death. Patients interrupting cyclic calorie restriction for any reason other than disease progression may continue the maintenance treatment with atezolizumab alone, if clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance treatment with cyclic, 5-day calorie restriction plus atezolizumab | Experimental | Dietary Supplement: Cyclic, 5-day calorie restriction, Drug: AtezolizumabThe experimental maintenance treatment will consist of: * triweekly cycles of 5-day calorie restriction (on days -2 through 2 of each cycle) in combination with * atezolizumab (at a dose of 1200 mg, administered intravenously on day 0 of each cycle) The experimental maintenance treatment will be administered until the occurrence of unacceptable toxic effects, disease progression, consent withdrawal or patient death. Patients interrupting cyclic calorie restriction for any reason other than disease progression may continue the maintenance treatment with atezolizumab alone, if clinically indicated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants who are able to comply with the requirements and restrictions listed in the Informed Consent Form and the study protocol (there is no separate Informed Consent Form for entering the maintenance phase)
- Signature of the informed consent form for those patients who have not previously participated to the induction phase of the study
- Age greater than or equal to 18 years and less than or equal to 75 years
- Willingness and ability to comply with the prescribed cyclic, 5-day calorie restriction regimen, the scheduled visits, treatment plans, laboratory tests and other procedures
- Histologically or cytologically confirmed diagnosis of small-cell lung cancer (SCLC).
Key exclusion criteria (27 listed)
- Prior systemic treatment for ES SCLC, with the exception for first-line chemoimmunotherapy induction with 4 triweekly cycles of atezolizumab plus carboplatin and etoposide. Patients who received prior concurrent chemoradiotherapy for limited-stage (LS) disease may be enrolled if concurrent chemoradiotherapy was concluded at least three months before enrollment.
- Patient has not available archival tumor tissue or has only cytological material without cytoincluded material available.
- The patient has not recovered from immune-related AEs of grade 2 or higher from the induction phase with atezolizumab plus carboplatin and etoposide. Patients with adequately-treated, controlled, immune-related skin rash of grade 2 or adequately-treated, controlled, endocrinopathies of grade 2 on replacement therapy can be enrolled.
- Body mass index (BMI) < 19 kg/m2.
- Unintentional weight loss ≥ 5% in the previous 3 months, unless the patient has a BMI > 22 kg/m2 and weight loss has been lower than 10% at the time of enrollment in the study; or unintentional weight loss ≥ 10% in the previous 3 months, unless the patient has a BMI > 25 kg/m2 and weight loss has been lower than 15% at the time of the enrollment in the study. In all cases, weight must have been stable for at least one month before study enrollment.
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 |
|---|---|---|
| Cyclic, 5-day calorie restrictionCyclic, 5-day, calorie-restricted (about 600 Kcal on day 1; about 300 Kcal on days 2 to 5), plant-based, low-protein, low-carbohydrate diet. | Dietary supplement | Maintenance treatment with cyclic, 5-day calorie restriction plus atezolizumab |
| AtezolizumabAtezolizumab 1200 mg administered intravenously. | Drug | Maintenance treatment with cyclic, 5-day calorie restriction plus atezolizumab |
Primary outcome
PFS rate at 6 months
Time frame: 6 months from experimental maintenance treatment initiation
The percentage of patients not experiencing disease progression or death from any cause after 6 months from experimental maintenance treatment initiation
4 secondary outcomes
PFS
Time frame: Up to 75 months from experimental maintenance treatment initiation
OS
Time frame: Up to 75 months from experimental maintenance treatment initiation
Compliance
Time frame: Up to 75 months from experimental maintenance treatment initiation
Adverse events
Time frame: Up to 75 months from experimental maintenance treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 33446664Rudin CM, Brambilla E, Faivre-Finn C, Sage J. Small-cell lung cancer. Nat Rev Dis Primers. 2021 Jan 14;7(1):3. doi: 10.1038/s41572-020-00235-0.
- Background: PubMed 30280641Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
- Background: PubMed 33439693Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.
- Background: PubMed 35121837Ajona D, Ortiz-Espinosa S, Lozano T, Exposito F, Calvo A, Valencia K, Redrado M, Remirez A, Lecanda F, Alignani D, Lasarte JJ, Macaya I, Senent Y, Bertolo C, Sainz C, Gil-Bazo I, Eguren-Santamaria I, Lopez-Picazo JM, Gonzalez A, Perez-Gracia JL, de Andrea CE, Vicent S, Sanmamed MF, Montuenga LM, Pio R. Short-term starvation reduces IGF-1 levels to sensitize lung tumors to PD-1 immune checkpoint blockade. Nat Cancer. 2020 Jan;1(1):75-85. doi: 10.1038/s43018-019-0007-9. Epub 2020 Jan 13.
- Background: PubMed 34789537Vernieri C, Fuca G, Ligorio F, Huber V, Vingiani A, Iannelli F, Raimondi A, Rinchai D, Frige G, Belfiore A, Lalli L, Chiodoni C, Cancila V, Zanardi F, Ajazi A, Cortellino S, Vallacchi V, Squarcina P, Cova A, Pesce S, Frati P, Mall R, Corsetto PA, Rizzo AM, Ferraris C, Folli S, Garassino MC, Capri G, Bianchi G, Colombo MP, Minucci S, Foiani M, Longo VD, Apolone G, Torri V, Pruneri G, Bedognetti D, Rivoltini L, de Braud F. Fasting-Mimicking Diet Is Safe and Reshapes Metabolism and Antitumor Immunity in Patients with Cancer. Cancer Discov. 2022 Jan;12(1):90-107. doi: 10.1158/2159-8290.CD-21-0030. Epub 2021 Nov 17.
- Background: PubMed 35810555Ligorio F, Fuca G, Provenzano L, Lobefaro R, Zanenga L, Vingiani A, Belfiore A, Lorenzoni A, Alessi A, Pruneri G, de Braud F, Vernieri C. Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. Eur J Cancer. 2022 Sep;172:300-310. doi: 10.1016/j.ejca.2022.05.046. Epub 2022 Jul 8.
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Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Filippo de Braud, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclic, 5-day calorie restriction and Atezolizumab in people with Small Cell Lung Carcinoma, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 18 inclusion and 27 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: opening soon, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Vernieri, MD, PhD ((+39) 02 2390 3066, claudio.vernieri@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS rate at 6 months (time frame: 6 months from experimental maintenance treatment initiation). 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 NCT05703997, which also lists 6 linked publications.
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 30 Jan 2023.