Clinical Trials for Small Cell Lung Cancer

Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: This study enrolls Black/African American adults with advanced or metastatic NSCLC (EGFR/ALK/ROS1 wild-type), who are treatment-naïve in this setting, to receive standard-of-care pembrolizumab (an anti–PD-1 checkpoint inhibitor) alone or with chemotherapy. All interventions are FDA-approved, and cohort assignment is based on biomarkers such as PD-L1 and ctDNA levels.

ClinicalTrials.gov ID: NCT06745882

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic non-squamous NSCLC who are treatment-naïve for advanced disease and lack actionable genomic alterations, testing the combination of telisotuzumab adizutecan (an anti-c-Met antibody-drug conjugate with a topoisomerase I inhibitor payload) and the PD-1 inhibitor budigalimab versus standard of care regimens. Patients with uncontrolled CNS metastases or significant interstitial lung disease are excluded.

ClinicalTrials.gov ID: NCT06772623

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

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.

HealthScout AI summary: This trial enrolls adults with metastatic or locally advanced thoracic tumors, including NSCLC, that have homozygous MTAP-deletion, and evaluates the safety and preliminary efficacy of AMG 193, an oral MTA-cooperative PRMT5 inhibitor targeting MTAP-deleted cells, as monotherapy or in combination with standard chemotherapies, immunotherapy, or sotorasib for KRAS G12C-mutated cases. Key subpopulations include those with specific NSCLC subtypes, KRAS G12C mutations, or active brain metastases.

ClinicalTrials.gov ID: NCT06333951

Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination with Low Dose Radiotherapy in Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors with Bone Metastases

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.

HealthScout AI summary: This trial enrolls adults with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases who have progressed after standard therapies, to receive allogeneic gamma delta T-cell infusions (KB-GDT-01, an off-the-shelf cell therapy leveraging innate anti-tumor immune activity) in combination with fractionated low-dose radiotherapy. Patients must have ECOG 0-1 and all disease sites must be amenable to radiotherapy.

ClinicalTrials.gov ID: NCT06069570

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors, including primary brain tumors, who have exhausted standard therapies, with dedicated cohorts for BRAF-mutant melanoma and other BRAF-mutated solid tumors; patients receive PF-07799544, a novel oral brain-penetrant MEK inhibitor, alone or in combination with a pan-mutant BRAF inhibitor (PF-07799933) or encorafenib, depending on tumor type and molecular profile.

ClinicalTrials.gov ID: NCT05538130

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors

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.

HealthScout AI summary: This trial enrolls adults with advanced, previously treated KRAS G12D-mutant solid tumors (excluding those with CNS involvement or prior direct RAS inhibitor use) to receive the selective KRAS G12D inhibitor RMC-9805, either as monotherapy or combined with the RAS(ON) multi-selective inhibitor RMC-6236. RMC-9805 acts as a molecular glue inducing covalent modification of KRAS G12D, while RMC-6236 targets multiple active KRAS G12X mutations.

ClinicalTrials.gov ID: NCT06040541

A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: This trial enrolls adults with treatment-naïve, stage IV non-squamous NSCLC (EGFR/ALK/ROS1 negative, ECOG 0–1) and randomizes them to ABP 234, a PD-1 inhibitor biosimilar, or reference pembrolizumab, each given with platinum-based chemotherapy and pemetrexed. Key exclusions include prior systemic therapy for advanced disease, actionable oncogenic drivers, squamous histology, and active CNS metastases.

ClinicalTrials.gov ID: NCT06311721

A Platform Study of RAS(ON) Inhibitor Combinations in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic RAS-mutated NSCLC (including KRAS G12C and G12D subtypes) who have progressed on standard therapies, testing investigational RAS(ON) inhibitors—RMC-6291 (KRAS G12C-selective), RMC-6236 (multi-selective RAS), and RMC-9805 (KRAS G12D-selective via cyclophilin A tri-complex)—alone or combined with pembrolizumab or platinum-based chemotherapies. Eligible patients must have ECOG 0–1 and adequate organ function.

ClinicalTrials.gov ID: NCT06162221

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (including HNSCC, NSCLC, mCRC, and PDAC) who have progressed on or lack standard therapies, to evaluate [225Ac]-FPI-2068, an investigational targeted alpha-emitting radiopharmaceutical directed against EGFR and c-MET, with or without FPI-2053 (a bispecific EGFR/c-MET antibody), and includes [111In]-FPI-2107 for diagnostic imaging.

ClinicalTrials.gov ID: NCT06147037

ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung 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.

HealthScout AI summary: This trial enrolls adults with metastatic NSCLC or extensive stage SCLC who have progressed after at least one line of systemic therapy and are eligible for gemcitabine/docetaxel; participants receive weekly ADI-PEG 20 (a pegylated arginine deiminase that depletes extracellular arginine), combined with gemcitabine and docetaxel, followed by ADI-PEG 20 maintenance.

ClinicalTrials.gov ID: NCT05616624