Clinical Trials for Small Cell Lung Cancer

A Phase I/II Trial of Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High Grade Neuroendocrine Cancers

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 recurrent small cell lung cancer or other high‑grade neuroendocrine carcinomas (measurable disease; ECOG 0–2) receive lurbinectedin IV Day 1 plus berzosertib (ATR kinase inhibitor that abrogates S/G2 checkpoint via CHK1 to potentiate DNA‑damage cytotoxicity) IV Days 1–2 every 21 days. Phase I includes advanced solid tumors post‑chemotherapy for dose finding; key exclusions include uncontrolled comorbidities, active infections, strong CYP3A modulators, and untreated/symptomatic CNS disease.

ClinicalTrials.gov ID: NCT04802174

Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-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: Adults with extensive-stage SCLC that is SSTR-positive by PET (≥50% of measurable metastases SSTR+) and treatment-naive or ≤1 prior cycle of platinum/etoposide plus PD-L1 inhibitor receive first-line carboplatin/etoposide/atezolizumab combined with RYZ101 (225Ac-DOTATATE), an alpha-emitting radiopharmaceutical targeting SSTR2. Aims to define RP2D and assess safety/early activity of adding SSTR2-targeted alpha therapy to standard chemo-immunotherapy.

ClinicalTrials.gov ID: NCT05595460

A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)

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 PD‑1/PD‑L1–refractory extensive-stage SCLC after exactly one prior platinum+PD‑1/L1 regimen are enrolled to receive investigational immunotherapy or ADC regimens, as monotherapy or combined with pembrolizumab. Arms include pembrolizumab+quavonlimab (anti–CTLA‑4), pembrolizumab+quavonlimab+lenvatinib (VEGFR/FGFR TKI), pembrolizumab+MK‑4830 (anti‑ILT4), favezelimab (anti‑LAG‑3)+pembrolizumab, and raludotatug deruxtecan (CDH6‑targeted topoisomerase I ADC).

ClinicalTrials.gov ID: NCT04938817

A Phase II Study of Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

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 small cell carcinoma of the bladder or other high‑grade neuroendocrine tumors of the urinary tract (including mixed histology), with measurable progressive disease after, ineligible for, or refusing platinum/etoposide (ECOG 0–2), receive lurbinectedin IV q21d; ICI‑naive, ICI‑eligible patients may also receive avelumab. Lurbinectedin is a selective transcription inhibitor; avelumab is a PD‑L1–blocking antibody.

ClinicalTrials.gov ID: NCT06228066

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)

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 SCLC that has progressed after exactly one prior platinum-based regimen (measurable disease, ECOG 0–1) are randomized to one of three IV dosing regimens of tarlatamab, a DLL3×CD3 bispecific T‑cell engager redirecting T cells against DLL3-expressing tumor cells. No control arm; key exclusions include symptomatic CNS/leptomeningeal disease, active autoimmune disease, ILD/pneumonitis, prior DLL3-directed therapy, and recent serious cardiac events.

ClinicalTrials.gov ID: NCT06745323

IIT2022-05-Sankar-BELIEVE: Phase II Study of Bevacizumab in Combination With Chemoimmunotherapy and Maintenance Atezolizumab in Patients With Extensive Stage Small Cell Lung Cancer and Liver Metastases

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 treatment-naïve extensive-stage small cell lung cancer and radiographic liver metastases receive carboplatin/etoposide plus atezolizumab (anti–PD-L1) and bevacizumab (anti–VEGF) for 4 cycles, followed by maintenance atezolizumab/bevacizumab. Includes ECOG 0–2, measurable disease, and allows selected stable/asymptomatic brain metastases; excludes significant bleeding/thromboembolic risk, uncontrolled hypertension, recent major surgery, active autoimmune disease requiring therapy, and active HBV.

ClinicalTrials.gov ID: NCT05588388

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

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 advanced/metastatic HER2-negative breast cancer (TNBC or HR+/HER2− post-CDK4/6 and chemo/ADC) or previously treated non-squamous NSCLC receive datopotamab deruxtecan (TROP2-directed ADC delivering a topoisomerase I inhibitor) plus prophylactic dexamethasone mouthwash. The study assesses whether short-course steroid mouthwash during the first three cycles reduces Dato-DXd–associated stomatitis while patients continue Dato-DXd q3w.

ClinicalTrials.gov ID: NCT06974604

DISCERN: Dual Immune Strategy Versus Single Checkpoint Inhibition Efficacy Response in PDL-1 Negative Non-Small Cell Lung Cancer (NSCLC)

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 stage IV, PD-L1–negative NSCLC without actionable drivers and detectable baseline ctDNA are randomized to standard chemo plus pembrolizumab versus chemo plus dual checkpoint blockade (nivolumab [PD-1] + ipilimumab [CTLA-4]), with maintenance per histology. Aims to assess early molecular response (ctDNA clearance by Cycle 4 Day 1) and key clinical outcomes; treated/stable CNS metastases allowed.

ClinicalTrials.gov ID: NCT06364917

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

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: Untreated adults with locally advanced unresectable or metastatic non-squamous NSCLC that overexpresses HER2 and has PD-L1 TPS &lt;50%, without actionable driver alterations or HER2 mutation. Randomized to trastuzumab deruxtecan (HER2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor) plus pembrolizumab versus standard pemetrexed/platinum plus pembrolizumab.

ClinicalTrials.gov ID: NCT06899126

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

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 locally advanced or metastatic solid tumors eligible for on-label PD-1 therapy (nivolumab or pembrolizumab) are randomized in a crossover design to receive standard PD-1 inhibitors via subcutaneous versus intravenous administration, assessing patient/clinician preference, satisfaction, QoL, safety, and selected clinical outcomes. Includes PD-(L)1–naïve patients or those willing to switch; excludes prior severe hypersensitivity and transplant history.

ClinicalTrials.gov ID: NCT07223424