Clinical Trials for Small Cell Lung Cancer

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.

HealthScout 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 Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).

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 DLL3-expressing advanced neuroendocrine cancers—including relapsed/refractory SCLC after platinum, treatment-emergent or de novo neuroendocrine prostate cancer, and other high-grade NETs lacking effective options—receive gocatamig (HPN328), a trispecific T-cell engager targeting DLL3/CD3 with albumin-binding for half-life, as IV monotherapy on varied schedules or in combination with atezolizumab (PD-L1 inhibitor) or ifinatamab deruxtecan (B7-H3 ADC). Key exclusions include active/untreated CNS disease, significant autoimmune/immunosuppression, recent major cardiovascular events, uncontrolled viral infections, and interstitial lung disease.

ClinicalTrials.gov ID: NCT04471727

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

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: Enrolls adults with recurrent SCLC or extra‑pulmonary small cell neuroendocrine cancers after ≥1 prior platinum, and HRD solid tumors that progressed on or shortly after PARP inhibitors; requires measurable disease and allows treated/stable brain mets. Investigational therapy combines sacituzumab govitecan (Trop‑2–directed ADC delivering SN‑38) on days 1/8 with berzosertib (ATR kinase inhibitor) on days 2/9 of 21‑day cycles.

ClinicalTrials.gov ID: NCT04826341

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

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

A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)

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: Previously untreated adults with extensive-stage SCLC (ECOG 0–1) are randomized to serplulimab (PD-1 inhibitor) plus carboplatin/etoposide versus atezolizumab (PD-L1 inhibitor) plus carboplatin/etoposide as first-line therapy. Key exclusions include mixed histology, significant cardiac issues, hypersensitivity to study drugs, and pregnancy.

ClinicalTrials.gov ID: NCT05468489

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

A Phase I Clinical Trial of Carfilzomib in Combination With Sotorasib in Patients With KRASG12C Mutated Advanced Non-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.

HealthScout AI summary: This trial evaluates the combination of carfilzomib, a proteasome inhibitor, and sotorasib, a KRAS G12C inhibitor, in adults with advanced or metastatic KRAS G12C-mutated non-small cell lung cancer who have progressed after previous KRAS inhibitor treatments.

ClinicalTrials.gov ID: NCT06249282