Clinical Trials for Small Cell Lung Cancer

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

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors

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 advanced/metastatic solid tumors refractory to standard therapy (mCRPC, metastatic breast cancer subtypes including TNBC, HR+/HER2− or HER2-low, HR−/HER2+, NSCLC, CRC, PDAC) receive MBRC-201, an investigational antibody‑drug conjugate targeting a tumor-associated antigen and delivering a likely topoisomerase I inhibitor payload. Requires ECOG 0–2 and measurable disease in expansion/Phase 2; excludes active CNS disease and prior camptothecin‑payload ADCs in later phases.

ClinicalTrials.gov ID: NCT07145255

A Phase 1b Study of Gilteritinib in Participants With Locally Advanced or Metastatic NSCLC With ALK Rearrangement After Prior Treatment With an ALK Inhibitor

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 ALK-rearranged, locally advanced/metastatic NSCLC who have progressed on prior ALK TKI (including post-alectinib or post-lorlatinib) receive oral gilteritinib, a FLT3/ALK tyrosine kinase inhibitor, with intra-patient dose escalation based on tolerability and disease control. Excludes symptomatic CNS/LM disease and significant cardiac/QTc risks; assesses safety with secondary efficacy endpoints (including intracranial response).

ClinicalTrials.gov ID: NCT07140016

A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer

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: Enrolling adults with newly diagnosed extensive-stage (metastatic/recurrent) small-cell lung cancer (ECOG 0–2) with measurable disease, including treated/stable asymptomatic brain metastases and select asymptomatic untreated brain metastases without edema. Patients receive first-line tarlatamab IV monotherapy (DLL3×CD3 bispecific T-cell engager redirecting T cells to DLL3-expressing SCLC) on a window-of-opportunity basis, with early progressors at 4 weeks transitioning to standard platinum chemotherapy plus an immune checkpoint inhibitor, and close monitoring for CRS/ICANS.

ClinicalTrials.gov ID: NCT07423585

Feasibility Trial of Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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: Enrolls adults with HPV-negative, PD-L1 CPS >1 recurrent/metastatic head and neck squamous cell carcinoma, no prior checkpoint inhibitor therapy, and an ultrasound- and biopsy-accessible measurable lesion. Patients receive pembrolizumab, an anti–PD-1 antibody, with Definity perflutren microbubbles and tumor-directed ultrasound-induced cavitation intended to enhance intratumoral drug delivery and immune response.

ClinicalTrials.gov ID: NCT07501650