Extensive Stage Small Cell Lung CancerPhase 1/2NCT05142696
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
A Phase 1/2 study testing [177Lu]Lu-DOTA-TATE, Atezolizumab and [68Ga]Ga-DOTA-TATE in people with Extensive Stage Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 27 sites in 12 countries.
Trial summary
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- [177Lu]Lu-DOTA-TATE, Atezolizumab and [68Ga]Ga-DOTA-TATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 27 sitesin 12 countries
- Study dates
- 13 Jul 2022to 7 Mar 2028
- Phase
- Phase 1/2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is >= 18 years on the day of signing informed consent form
- Histologically or cytologically confirmed ES-SCLC
- Presence of measurable disease
- No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
- ECOG status =< 1
- Provision of tumor tissue to support exploratory biomarker analysis
- Life expectancy of >= 6 months
Who cannot join
- Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
- Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 1 Day 1
- History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
- Known hypersensitivity to the active substances or any of the excipients of the study drugs
- Concurrent participation in another therapeutic clinical study
Trial locations and contacts
27 sites in 12 countries.
27 sites in 12 countries
United States7 sites
University Cancer and Blood Center LLC
Athens, Georgia, 30607
University Hospitals Of Cleveland
Cleveland, Ohio, 44106
Hackensack University Medical Ctr
Hackensack, New Jersey, 07601
University of Kentucky
Lexington, Kentucky, 40536
AdventHealth
Orlando, Florida, 32804
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
St Louis University
St Louis, Missouri, 63104
Spain4 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Málaga, 29010
France3 sites
Novartis Investigative Site
Lille, 59000
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Montpellier, 34298
Israel3 sites
Novartis Investigative Site
Beersheba, 8457108
Novartis Investigative Site
Ramat Gan, 5265601
Novartis Investigative Site
Tel Aviv, 6423906
China2 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Shanghai, 200032
South Korea2 sites
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05505
United Kingdom1 site
Novartis Investigative Site
Guildford, Surrey, GU2 7XX
About this study
Official title: A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.
Read the detailed description
The study for each participant consists of a Screening period, a Treatment period that includes an Induction treatment period and a Maintenance treatment period, and a Follow-up period.
The study will consist of a Phase Ib dose escalation with concurrent backfill part and a randomised controlled Phase II part.
During the screening period of up to 28 days before starting SCLC treatment, each participant will be assessed for somatostatin receptor (SSTR) expression by [68Ga]Ga-DOTA-TATE imaging PET/scan.
The dose escalation part in this study will be guided by the dose limiting toxicity (DLT) rate observed during the DLT period. To achieve a more robust dataset and to aid dose decisions, additional participants may be backfilled in each dose level.
Upon declaring RD, a 1:1 randomised Phase II with approximately 140 participants with newly diagnosed ES-SCLC will be enrolled and receive either [177Lu]Lu-DOTA-TATE at the RD in combination with carboplatin, etoposide and atezolizumab (experimental arm) or carboplatin, etoposide and atezolizumab alone (control arm).
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- [177Lu]Lu-DOTA-TATE, Atezolizumab, [68Ga]Ga-DOTA-TATE, Carboplatin, Etoposide
- Keywords
- Extensive Stage Small Cell Lung Cancer, ES-SCLC, Radioligand therapy, RLT, [177Lu]Lu-DOTA-TATE, Lutathera, Lutetium (177Lu) oxodotreotide, Lutetium Lu 177 dotatate, atezolizumab, carboplatin, etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-DOTA-TATEDrug
Also called Lutathera, Lutetium (177Lu) oxodotreotide, Lutetium Lu 177 dotatate
Solution for infusion of [177Lu]Lu-DOTA-TATE will be administered as follows:
- 2 administrations during the induction period on either Day 3, 4 or 5 of Week 1 and on Week 7 Day 3
- 1 to 4 administrations during the maintenance period on Week 13 Day 1, Week 16 Day 1, Week 19 Day 1 and Week 22 Day 1, depending on the dose assessed
AtezolizumabDrug
Atezolizumab 1200 mg on Day 1 from Cycle 2 every 3 weeks in induction and maintenance period
[68Ga]Ga-DOTA-TATEDrug
2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi)
CarboplatinOther
Four cycles of carboplatin AUC 5 on Day 1 every 3 weeks (Weeks 1, 4, 7 and 10) in induction period
EtoposideOther
Four cycles of etoposide 100 mg/m2 on Day 1-3, every 3 weeks (Weeks 1, 4, 7 and 10) in induction period
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 (DL1) | Experimental | Dose Level 1 (DL1): [177Lu]Lu-DOTA-TATE 100 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 100 mCi plus atezolizumab 1200 mg in the maintenance period. Receives: Drug: [177Lu]Lu-DOTA-TATE; Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
| Dose Level 2a (DL2a) | Experimental | Dose Level 2a (DL2a): [177Lu]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 150 mCi plus atezolizumab 1200 mg in the maintenance period. Receives: Drug: [177Lu]Lu-DOTA-TATE; Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
| Dose Level 2b (DL2b) | Experimental | Dose Level 2b (DL2b): [177Lu]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumad 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 in the maintenance period. Receives: Drug: [177Lu]Lu-DOTA-TATE; Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
| Dose Level 3a (DL3a) | Experimental | Dose Level 3a (DL3a): [177Lu]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 mg in the maintenance period. Receives: Drug: [177Lu]Lu-DOTA-TATE; Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
| Dose Level 3b (DL3b) | Experimental | Dose Level 3b (DL3b): [177Lu]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period. Receives: Drug: [177Lu]Lu-DOTA-TATE; Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
| Dose Level 4 (DL4) | Experimental | Dose Level 4 (DL4): [177Lu]Lu-DOTA-TATE 250 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period. Receives: Drug: [177Lu]Lu-DOTA-TATE; Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
| Phase II Experimental arm | Experimental | [177Lu]Lu-DOTA-TATE at recommended dose declared in phase I part in combination with carboplatin, etoposide and atezolizumab (experimental arm) Receives: Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
| Phase II Control arm | Other | Carboplatin, etoposide and atezolizumab alone (control arm) Receives: Drug: Atezolizumab; Drug: [68Ga]Ga-DOTA-TATE; Other: Carboplatin; Other: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications with an onset within the first cycle of initiation of [177Lu]Lu-DOTA-TATE treatment. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for AE grading.
Measured: Within the first six weeks of [177Lu]Lu-DOTA-TATE treatment]
Phase ll: Overall survival (OS)
To assess efficacy of [177Lu]Lu-DOTA-TATE in combination with atezolizumab, carboplatin, and etoposide (experimental arm) versus standard of care consisting of carboplatin, etoposide, and atezolizumab (control arm) in terms of overall survival
Measured: In the phase II part: From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis)
Secondary outcomes (12)
Phase lb: Objective Response Rate (ORR) based on Investigator assessment
Objective Response Rate (ORR) defined as the proportion of participants with a best overall confirmed complete response (CR) or partial response (PR) as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator assessment
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase lb: Duration of Response (DOR)
Duration of Response (DOR), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer. Participants continuing without progression or death due to underlying cancer will be censored at the date of their last adequate tumor assessment. DOR will be listed and summarized by dose level combination and checkpoint inhibitor in Phase Ib and by treatment group in Phase II part for all participants in the FAS with confirmed BOR of CR or PR.
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase lb: Progression Free Survival (PFS) based on Investigator assessment
Progression Free Survival (PFS) is defined as the time from the date of first dose to the date of the first documented progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1. If no PFS event is observed, PFS will be censored at the date of the late adequate tumor assessment prior to data cut-off date and start of new anti-neoplastic therapy, whichever comes first.
PFS will be analyzed in the FAS population according to the assigned dose level combination and checkpoint inhibitor in Phase Ib and by treatment group in Phase II part. The PFS distribution will be estimated using the Kaplan-Meier method, and the Kaplan-Meier curves, medians and 95% confidence intervals of the medians will be presented for each dose level combination and checkpoint inhibitor in Phase Ib and by treatment group in Phase II part.
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final OS analysis)
Phase lb: Overall Survival (OS)
OS is defined as the time from date of first dose to date of death due to any cause in Phase Ib. If a participant is not known to have died, then OS will be censored at the latest date the participant was known to be alive (on or before the cut-off date).
OS will be analyzed in the FAS population according to the assigned dose cohort and checkpoint inhibitor in Phase Ib. The OS distribution will be estimated using the Kaplan-Meier method, and the Kaplan-Meier curves, medians and 95% confidence intervals of the medians will be presented for each dose level combination and checkpoint inhibitor in Phase Ib Kaplan-Meier estimates with 95% confidence intervals every 6 months will be summarized as well by dose level combination, checkpoint inhibitor in Phase Ib and treatment group in Phase II part.
Measured: From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis)
Phase ll: Progression free survival (PFS) by investigator assessment
Progression Free Survival (PFS) is defined as the time from the date of first dose to the date of the first documented progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1. If no PFS event is observed, PFS will be censored at the date of the late adequate tumor assessment prior to data cut-off date and start of new anti-neoplastic therapy, whichever comes first.
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final OS analysis)
Phase ll: Objective Response Rate (ORR) by investigator assessment
Objective response rate (ORR) is defined as the percentage of participants with confirmed best overall confirmed complete response (CR) or partial response (PR), as per local review and according to RECIST 1.1 by Investigator assessment.
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase ll: Duration of Response (DOR) by investigator assessment
Duration of Response (DOR), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer. Participants continuing without progression or death due to underlying cancer will be censored at the date of their last adequate tumor assessment. DOR will be listed and summarized by dose level combination and checkpoint inhibitor in Phase Ib and by treatment group in Phase II part for all participants in the FAS with confirmed BOR of CR or PR.
Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Incidence and severity of adverse events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, and ECGs; dose interruptions, discontinuations, and reductions
To characterize the safety and tolerability of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and atezolizumab in induction treatment and with atezolizumab in maintenance treatment in newly diagnosed participants with ES-SCLC
Measured: From date of randomisation until date of progression or date of death from any cause, whichever comes first, assessed for up to 3 years
Incidence and severity of Adverse Events (AEs) and serious Adverse Events (SAEs) within 48 hours after [68Ga]Ga-DOTA-TATE infusion
To assess the safety and tolerability of [68Ga]Ga-DOTA-TATE in participants with newly diagnosed ES-SCLC
Measured: up to 48 hours following the start of [68Ga]Ga-DOTA-TATE administration]
Phase lb and II: Absorbed radiation doses of [177Lu]Lu-DOTA-TATE
To characterize the pharmacokinetics (PK) and dosimetry of [177Lu]Lu-DOTA-TATE in participants with newly diagnosed ES-SCLC
Measured: Week 7 Day 3
Phase lb: PK parameters of [177Lu]Lu-DOTA-TATE in blood
Blood samples for radioactivity measurement will be collected in all participants who undergo dosimetry assessments (i.e. first 3 participants at dose levels 1, 2a or 2b, 3a or 3b, and 4). For the rest of participants , blood samples will be taken before the start of [177Lu]Lu-DOTA-TATE infusion, at the end of infusion, and then at 2h, 6h after the end of [177Lu]Lu-DOTA-TATE infusion. Blood samples will be drawn in heparinized tubes. Radioactivity measurements on blood will be performed locally on site, using a gamma-counter.
Measured: Week 7 Day 3 (pre-dose, before the end of infusion, 2 hours post-dose, 6 hours post-dose), Week 7 Day 4 (24 hours post-dose), Week 7 Day 5 (48 hours post-dose), Week 8 Day 3 (168 hours post-dose)
Phase II: PK parameters of [177Lu]Lu-DOTA-TATE in blood
Blood samples for radioactivity measurement will be collected in approximately 10 participants who undergo dosimetry assesments. In the participants that will undergo dosimetry assessments, an additional whole body planar transmission scan with the participant needs to be performed for the qualification of the dosimetry setup before the first infusion of [177Lu]Lu-DOTA-TATE.
A SPECT/CT scan will be acquired after the 1st, 2nd, and 4th administration of [177Lu]Lu-DOTA-TATE.
Measured: Week 1 Day 3, Week 7 Day 3 (pre-dose, before the end of infusion, post-dose: 2 hours, 6 hours, 24 hours, 48 hours, 168 hours), Week 13 Day 1 (pre-dose, before the end of infusion, post-dose: 2 hours, 6 hours, 24 hours, 48 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start13 Jul 2022
- Primary completion7 Mar 2028 (estimated)
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142696
- Sponsor's protocol ID
- CAAA601A42101
- Other IDs
- 2021-004155-16, 2024-513185-19-00
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase
- ClinicalTrials.gov ID
- NCT05142696
- Acronym / sponsor ID
- CAAA601A42101
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Keywords
- Extensive Stage Small Cell Lung Cancer, ES-SCLC, Radioligand therapy, RLT, [177Lu]Lu-DOTA-TATE, Lutathera, Lutetium (177Lu) oxodotreotide, Lutetium Lu 177 dotatate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 7 Mar 2028 (estimated)
- First posted
- 2 Dec 2021 (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 study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.
Detailed description
The study for each participant consists of a Screening period, a Treatment period that includes an Induction treatment period and a Maintenance treatment period, and a Follow-up period.
The study will consist of a Phase Ib dose escalation with concurrent backfill part and a randomised controlled Phase II part.
During the screening period of up to 28 days before starting SCLC treatment, each participant will be assessed for somatostatin receptor (SSTR) expression by [68Ga]Ga-DOTA-TATE imaging PET/scan.
The dose escalation part in this study will be guided by the dose limiting toxicity (DLT) rate observed during the DLT period. To achieve a more robust dataset and to aid dose decisions, additional participants may be backfilled in each dose level.
Upon declaring RD, a 1:1 randomised Phase II with approximately 140 participants with newly diagnosed ES-SCLC will be enrolled and receive either [177Lu]Lu-DOTA-TATE at the RD in combination with carboplatin, etoposide and atezolizumab (experimental arm) or carboplatin, etoposide and atezolizumab alone (control arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 (DL1) | Experimental | Drug: [177Lu]Lu-DOTA-TATE, Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: EtoposideDose Level 1 (DL1): [177Lu]Lu-DOTA-TATE 100 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 100 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 2a (DL2a) | Experimental | Drug: [177Lu]Lu-DOTA-TATE, Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: EtoposideDose Level 2a (DL2a): [177Lu]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 150 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 2b (DL2b) | Experimental | Drug: [177Lu]Lu-DOTA-TATE, Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: EtoposideDose Level 2b (DL2b): [177Lu]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumad 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 in the maintenance period. |
| Dose Level 3a (DL3a) | Experimental | Drug: [177Lu]Lu-DOTA-TATE, Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: EtoposideDose Level 3a (DL3a): [177Lu]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 3b (DL3b) | Experimental | Drug: [177Lu]Lu-DOTA-TATE, Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: EtoposideDose Level 3b (DL3b): [177Lu]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 4 (DL4) | Experimental | Drug: [177Lu]Lu-DOTA-TATE, Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: EtoposideDose Level 4 (DL4): [177Lu]Lu-DOTA-TATE 250 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then [177Lu]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Phase II Experimental arm | Experimental | Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: Etoposide[177Lu]Lu-DOTA-TATE at recommended dose declared in phase I part in combination with carboplatin, etoposide and atezolizumab (experimental arm) |
| Phase II Control arm | Other | Drug: Atezolizumab, Drug: [68Ga]Ga-DOTA-TATE, Other: Carboplatin, Other: EtoposideCarboplatin, etoposide and atezolizumab alone (control arm) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is >= 18 years on the day of signing informed consent form
- Histologically or cytologically confirmed ES-SCLC
- Presence of measurable disease
- No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
- ECOG status =< 1
Key exclusion criteria (7 listed)
- Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
- Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 1 Day 1
- History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
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 |
|---|---|---|
| [177Lu]Lu-DOTA-TATEAlso: Lutathera, Lutetium (177Lu) oxodotreotide, Lutetium Lu 177 dotatateSolution for infusion of [177Lu]Lu-DOTA-TATE will be administered as follows: * 2 administrations during the induction period on either Day 3, 4 or 5 of Week 1 and on Week 7 Day 3 * 1 to 4 administrations during the maintenance period on Week 13 Day 1, Week 16 Day 1, Week 19 Day 1 and Week 22 Day 1, depending on the dose assessed | Drug | Dose Level 1 (DL1), Dose Level 2a (DL2a), Dose Level 2b (DL2b), Dose Level 3a (DL3a), Dose Level 3b (DL3b), Dose Level 4 (DL4) |
| AtezolizumabAtezolizumab 1200 mg on Day 1 from Cycle 2 every 3 weeks in induction and maintenance period | Drug | Dose Level 1 (DL1), Dose Level 2a (DL2a), Dose Level 2b (DL2b), Dose Level 3a (DL3a), Dose Level 3b (DL3b), Dose Level 4 (DL4), Phase II Control arm, Phase II Experimental arm |
| [68Ga]Ga-DOTA-TATE2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi) | Drug | Dose Level 1 (DL1), Dose Level 2a (DL2a), Dose Level 2b (DL2b), Dose Level 3a (DL3a), Dose Level 3b (DL3b), Dose Level 4 (DL4), Phase II Control arm, Phase II Experimental arm |
| CarboplatinFour cycles of carboplatin AUC 5 on Day 1 every 3 weeks (Weeks 1, 4, 7 and 10) in induction period | Other | Dose Level 1 (DL1), Dose Level 2a (DL2a), Dose Level 2b (DL2b), Dose Level 3a (DL3a), Dose Level 3b (DL3b), Dose Level 4 (DL4), Phase II Control arm, Phase II Experimental arm |
| EtoposideFour cycles of etoposide 100 mg/m2 on Day 1-3, every 3 weeks (Weeks 1, 4, 7 and 10) in induction period | Other | Dose Level 1 (DL1), Dose Level 2a (DL2a), Dose Level 2b (DL2b), Dose Level 3a (DL3a), Dose Level 3b (DL3b), Dose Level 4 (DL4), Phase II Control arm, Phase II Experimental arm |
Primary outcome
Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation
Time frame: Within the first six weeks of [177Lu]Lu-DOTA-TATE treatment]
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications with an onset within the first cycle of initiation of [177Lu]Lu-DOTA-TATE treatment. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for AE grading.
Phase ll: Overall survival (OS)
Time frame: In the phase II part: From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis)
To assess efficacy of [177Lu]Lu-DOTA-TATE in combination with atezolizumab, carboplatin, and etoposide (experimental arm) versus standard of care consisting of carboplatin, etoposide, and atezolizumab (control arm) in terms of overall survival
12 secondary outcomes
Phase lb: Objective Response Rate (ORR) based on Investigator assessment
Time frame: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase lb: Duration of Response (DOR)
Time frame: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase lb: Progression Free Survival (PFS) based on Investigator assessment
Time frame: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final OS analysis)
Phase lb: Overall Survival (OS)
Time frame: From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis)
Phase ll: Progression free survival (PFS) by investigator assessment
Time frame: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final OS analysis)
Phase ll: Objective Response Rate (ORR) by investigator assessment
Time frame: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Phase ll: Duration of Response (DOR) by investigator assessment
Time frame: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed for up to 3 years (estimated final Overall Survival (OS) analysis)
Incidence and severity of adverse events (AEs), serious AEs (SAEs), changes in hematology and chemistry values, vital signs, and ECGs; dose interruptions, discontinuations, and reductions
Time frame: From date of randomisation until date of progression or date of death from any cause, whichever comes first, assessed for up to 3 years
Incidence and severity of Adverse Events (AEs) and serious Adverse Events (SAEs) within 48 hours after [68Ga]Ga-DOTA-TATE infusion
Time frame: up to 48 hours following the start of [68Ga]Ga-DOTA-TATE administration]
Phase lb and II: Absorbed radiation doses of [177Lu]Lu-DOTA-TATE
Time frame: Week 7 Day 3
Phase lb: PK parameters of [177Lu]Lu-DOTA-TATE in blood
Time frame: Week 7 Day 3 (pre-dose, before the end of infusion, 2 hours post-dose, 6 hours post-dose), Week 7 Day 4 (24 hours post-dose), Week 7 Day 5 (48 hours post-dose), Week 8 Day 3 (168 hours post-dose)
Phase II: PK parameters of [177Lu]Lu-DOTA-TATE in blood
Time frame: Week 1 Day 3, Week 7 Day 3 (pre-dose, before the end of infusion, post-dose: 2 hours, 6 hours, 24 hours, 48 hours, 168 hours), Week 13 Day 1 (pre-dose, before the end of infusion, post-dose: 2 hours, 6 hours, 24 hours, 48 hours post-dose)
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 19 Aug 2026.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
27 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [177Lu]Lu-DOTA-TATE, Atezolizumab and [68Ga]Ga-DOTA-TATE in people with Extensive Stage Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 27 sites in 12 countries.
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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain, France, Israel, China and 7 more countries. 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?
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?
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?
Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation (time frame: Within the first six weeks of [177Lu]Lu-DOTA-TATE 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?
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 19 Aug 2026.