Clinical Trials for Small Cell Lung Cancer

A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

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.

HealthScout AI summary: This trial enrolls patients with stage IV or recurrent NSCLC who have progressed after platinum-based chemotherapy and prior anti-PD-1 or anti-PD-L1 therapy, comparing standard docetaxel plus ramucirumab versus the same regimen with the addition of cemiplimab (an anti-PD-1 antibody) to assess benefit in the post-immunotherapy setting.

ClinicalTrials.gov ID: NCT06616584

ResQ201A: Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic NSCLC who have progressed after one line of immune checkpoint inhibitor therapy, testing the combination of N-803 (an IL-15 superagonist that activates NK and CD8+ T cells), tislelizumab (anti-PD-1), and docetaxel versus docetaxel alone. Eligible patients may have any NSCLC histology or actionable mutations except ALK, and should have ECOG 0-2 and adequate organ function.

ClinicalTrials.gov ID: NCT06745908

A Phase I Dose Escalation / Dose Expansion Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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.

HealthScout AI summary: This trial enrolls patients with advanced, injectable metastatic or recurrent head and neck squamous cell carcinoma, NSCLC, melanoma, hepatocellular, renal, urothelial, cervical, or triple-negative breast cancer—regardless of anti-PD-1 status—to receive a single intratumoral injection of NBTXR3 (a hafnium oxide nanoparticle radioenhancer) activated by SABR, followed by anti-PD-1 therapy with nivolumab or pembrolizumab.

ClinicalTrials.gov ID: NCT03589339

A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients with Advanced Cancer with and Without Pembrolizumab

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors lacking standard options—including cohorts for pancreatic, gastric, NSCLC, colorectal, metastatic uveal melanoma (≤2 prior lines), PD‑1/L1–refractory cutaneous melanoma, and PD‑1/L1–relapsed solid tumors—receive oral LNS8801, a selective GPER agonist, as monotherapy or combined with pembrolizumab. Key exclusions include ERα‑positive malignancies, active CNS disease for combo, prior severe PD‑1/L1 irAEs (for combo), recent estrogen/ER‑directed therapy, and strong CYP modulators or PPIs.

ClinicalTrials.gov ID: NCT04130516

A Phase 1 Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Ovarian and Cervical Carcinoma, Sarcomas, and Neuroendocrine Tumors Including Small Cell Lung Cancer and Merkel Cell Carcinoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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.

HealthScout AI summary: Adults with metastatic or unresectable solid tumors lacking standard options, with expansion cohorts for ovarian cancer and Merkel cell carcinoma, receive FF-10850, a dihydrosphingomyelin-based liposomal topotecan (topoisomerase I inhibitor) IV on Days 1 and 15 of 28-day cycles at the RP2D of 2 mg/m². Single-agent therapy aims to assess safety and preliminary activity, with manageable hematologic toxicity observed and early responses in ovarian and Merkel cell cohorts.

ClinicalTrials.gov ID: NCT04047251

A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Tumors and Relapsed/Refractory SCLC

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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.

HealthScout AI summary: Single-arm study of oral chiauranib (ibcasertib), a multi-kinase inhibitor targeting VEGFR1/2/3, PDGFRα, c‑Kit, Aurora B, and CSF‑1R, in adults with advanced solid tumors (dose-escalation) and in relapsed/refractory SCLC after ≥2 prior regimens including platinum (expansion). Patients receive daily 28-day cycles at the RP2D (prior data suggest 50 mg), with safety/PK and preliminary efficacy endpoints.

ClinicalTrials.gov ID: NCT05271292

A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

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.

HealthScout AI summary: Adults with untreated extensive-stage SCLC eligible for first-line carboplatin/etoposide plus durvalumab are randomized to receive durvalumab/chemotherapy with or without tarlatamab, followed by maintenance durvalumab ± tarlatamab. Tarlatamab is an investigational DLL3×CD3 bispecific T‑cell engager designed to redirect T cells against DLL3-expressing SCLC.

ClinicalTrials.gov ID: NCT07005128

A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-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.

HealthScout AI summary: Adults with ES-SCLC after exactly one prior platinum regimen (± prior PD-(L)1), ECOG 0–1, and measurable disease are randomized to sacituzumab govitecan—an anti–Trop-2 antibody–drug conjugate delivering SN-38—vs investigator’s choice SOC (topotecan, or in Japan topotecan or amrubicin). Excludes prior topoisomerase I–targeting agents and active untreated CNS disease; treated/stable brain mets allowed.

ClinicalTrials.gov ID: NCT06801834

A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)

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.

HealthScout AI summary: Adults with extensive-stage SCLC who achieved CR/PR/SD after 3–4 cycles of first-line platinum–etoposide plus durvalumab (ECOG 0–1; treated/stable brain mets allowed) are randomized to maintenance tarlatamab plus durvalumab versus durvalumab alone. Tarlatamab is a DLL3-directed bispecific T-cell engager that redirects cytotoxic T cells to DLL3-expressing SCLC cells; key risks include CRS and neurologic events.

ClinicalTrials.gov ID: NCT06211036

A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile 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.

HealthScout AI summary: Adults with metastatic or unresectable rare non‑prostate GU cancers (high‑grade neuroendocrine, primary adenocarcinoma [urachal/non‑urachal], squamous cell of bladder/urinary tract, renal medullary carcinoma, or penile SCC) receive sacituzumab govitecan, with addition of atezolizumab for checkpoint inhibitor–naive patients. Sacituzumab govitecan is a Trop‑2–targeted antibody–drug conjugate delivering SN‑38 (topoisomerase I inhibitor), and atezolizumab is a PD‑L1 inhibitor.

ClinicalTrials.gov ID: NCT06161532