Clinical Trials for Small Cell Lung Cancer

RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with relapsed/refractory DLL3-expressing or DLL3-prevalent tumors (including SCLC, LCNEC, high-grade neuroendocrine tumors, and select NSCLC/other histologies) receive the DLL3-directed bispecific T‑cell engager tarlatamab plus external-beam radiation, given concurrently or sequentially depending on safety. Key risks include CRS/ICANS; includes extracranial and cranial RT cohorts with allowance for treated/stable brain mets and selected brain lesions.

ClinicalTrials.gov ID: NCT06814496

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with extensive-stage SCLC that has progressed after prior platinum and PD-1/PD-L1 therapy (ECOG 0–1, measurable disease) receive lurbinectedin plus trilaciclib. Lurbinectedin is a DNA-binding transcription inhibitor; trilaciclib is a transient CDK4/6 inhibitor given to protect hematopoietic stem/progenitor cells and reduce severe myelosuppression while assessing antitumor activity.

ClinicalTrials.gov ID: NCT05578326

A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with histologically confirmed SCLC and up to 10 brain metastases (KPS 60–100/ECOG 0–2), without prior brain RT or leptomeningeal disease, receive stereotactic radiosurgery to all lesions. Designed to evaluate intracranial control and short-term survival (6-month OS) with focal SRS instead of whole-brain radiotherapy.

ClinicalTrials.gov ID: NCT05419076

A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab as Second or Third Line Treatment for Small Cell Lung Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with extensive-stage SCLC progressing after platinum-based chemoimmunotherapy (chemo-sensitive or -resistant), ECOG 0–2, measurable disease, and no prior temozolomide are randomized to atezolizumab (anti–PD-L1) plus temozolomide with either a 5-day or extended 14–21 day oral schedule. Stable, asymptomatic brain metastases are allowed; outcomes include response rate, PFS (including intracranial), OS, and safety.

ClinicalTrials.gov ID: NCT04919382

RAndomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with extensive-stage SCLC who have not progressed after 4–6 cycles of platinum/etoposide plus atezolizumab (PR/SD), ECOG 0–2, ≤3 liver mets, and controlled brain mets are randomized to maintenance atezolizumab alone versus atezolizumab plus consolidation external-beam radiotherapy to all disease sites. Atezolizumab is an anti–PD-L1 monoclonal antibody; the study tests whether adding consolidation RT improves PFS/OS versus maintenance alone.

ClinicalTrials.gov ID: NCT04402788

A Phase II Trial of Lamivudine in Combination With Chemoimmunotherapy in Patients With Extensive Stage SCLC

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with extensive-stage SCLC (newly diagnosed or relapse ≥12 months after prior platinum) receive carboplatin/etoposide plus atezolizumab with added lamivudine, followed by maintenance lamivudine ± atezolizumab; patients unable to receive PD-L1 therapy may get chemo plus lamivudine alone. Lamivudine is an oral nucleoside reverse transcriptase inhibitor proposed to inhibit endogenous retroelement RT to reduce resistance and potentially modulate tumor-immune interactions.

ClinicalTrials.gov ID: NCT04696575

A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with extrapulmonary high-grade neuroendocrine neoplasms without standard options receive genotype-directed belinostat (HDAC inhibitor) as a 48-hour infusion combined with cisplatin and etoposide every 21 days, with optional belinostat maintenance. UGT1A1 status guides belinostat dose (lower for *28/*28 or any *60; higher for wild type or *1/*28), with exclusions for platinum-refractory disease, significant QT risk, and strong UGT1A1/CYP3A modulators.

ClinicalTrials.gov ID: NCT06406465

A Phase II Trial of Durvalumab and Ablative Radiation in Extensive-Stage Small Cell Lung Cancer (DARES)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Treatment-naïve adults with extensive-stage small cell lung cancer (ECOG 0–2), including those with treated/stable brain metastases and at least one lesion suitable for ablative RT, receive carboplatin/etoposide plus durvalumab (anti–PD-L1) with hypofractionated ablative radiation to selected lesions during cycle 2, followed by durvalumab maintenance. Excludes prior SCLC systemic/PD-(L)1/CTLA-4 therapy or thoracic RT and active autoimmune disease or uncontrolled infections.

ClinicalTrials.gov ID: NCT05068232

(TESSERACT): Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation (TBI)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with untreated extensive-stage SCLC (ECOG 0–2; controlled brain mets allowed) receive standard carboplatin/etoposide plus atezolizumab (PD-L1 inhibitor) with the investigational addition of low-dose total body irradiation and short-course hypofractionated RT to dominant disease sites. Maintenance atezolizumab follows, with primary focus on safety and PFS.

ClinicalTrials.gov ID: NCT06110572

A Phase I Study of Palliative Radiotherapy with Lurbinectedin in Patients with Extensive Stage Small Cell Lung Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with extensive-stage SCLC who progressed after first-line therapy and are receiving or eligible for lurbinectedin receive concurrent palliative external beam radiotherapy (5–10 fractions) plus lurbinectedin every 21 days. Lurbinectedin is a DNA minor-groove binder that inhibits oncogenic transcription via RNA polymerase II stalling and depletes tumor-associated macrophages; treated brain metastases allowed, ECOG 0–2 (≤3 permitted).

ClinicalTrials.gov ID: NCT05244239