Clinical Trials for Small Cell Lung Cancer

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Advanced KRAS Mutated 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.

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 is enrolling patients with unresectable stage III/IV non-small cell lung cancer harboring specific KRAS mutations (G12C, G12V, G12D, G12A, G13D, or G12R) who have not had prior therapy for advanced disease, to evaluate a KRAS-targeted long peptide vaccine (designed to elicit immune responses against mutant KRAS) combined with poly-ICLC adjuvant, nivolumab (PD-1 inhibitor), and ipilimumab (CTLA-4 inhibitor). Key exclusions include prior immunotherapy, active autoimmune disease, and untreated or symptomatic brain metastases.

ClinicalTrials.gov ID: NCT05254184

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, recurrent, or metastatic solid tumors (including platinum-resistant ovarian cancer, triple-negative breast cancer, squamous cell carcinoma of the anus or head and neck, non-small cell lung cancer, and uterine serous cancer) who have progressed on all standard therapies, to receive SMP-3124LP, a novel liposomal CHK1 inhibitor given by intravenous infusion. SMP-3124LP targets the DNA damage response pathway and is being assessed for safety, tolerability, and preliminary efficacy.

ClinicalTrials.gov ID: NCT06526819

Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of a CDAC Degrading EGFR, BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults with advanced or metastatic non-small cell lung cancer harboring EGFR activating mutations who have progressed on or are ineligible for standard EGFR-TKI therapies (including cases with resistance mutations like C797S) may enroll to receive BG-60366, an oral chimeric degradation activation compound that selectively degrades mutant EGFR. Prior small cell transformation, symptomatic CNS metastases, previous fourth-generation EGFR-TKIs, and significant interstitial lung disease are exclusion criteria.

ClinicalTrials.gov ID: NCT06685718

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Selected Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 GPC3-expressing solid tumors (including hepatocellular carcinoma, AFP-producing gastric cancer, extragonadal yolk sac tumors, non-dysgerminomas, or GPC3-positive squamous NSCLC) who have ECOG 0-1. Patients will receive the investigational bispecific antibody BGB-B2033 (targeting GPC3 and 4-1BB) alone or combined with the anti-PD-1 antibody tislelizumab.

ClinicalTrials.gov ID: NCT06427941

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B694, an Autologous Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults with Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 recurrent, unresectable, locally advanced, or metastatic solid tumors—including colorectal, pancreatic, NSCLC, ovarian cancer, mesothelioma, and others—that express mesothelin (MSLN) and have lost HLA-A*02 expression, who are heterozygous for HLA-A*02. Eligible patients receive a single infusion of A2B694, an autologous CAR T-cell therapy engineered with a logic-gated Tmod system to selectively target MSLN-positive, HLA-A*02-negative tumor cells.

ClinicalTrials.gov ID: NCT06051695

A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Eligible patients are adults with metastatic or advanced solid tumors—including breast, non-small cell lung (EGFR-mutant or wild-type), gastric, gastroesophageal, or colorectal cancer—who have progressed on, are intolerant to, or lack access to standard therapies. The investigational treatment is DM001, a bispecific antibody-drug conjugate targeting TROP2 and EGFR and delivering a topoisomerase I inhibitor, administered intravenously every 21 days.

ClinicalTrials.gov ID: NCT06475937

An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 study enrolls adults with locally advanced unresectable or metastatic solid tumors harboring KRAS G12C mutations who have progressed on or are intolerant to standard therapy, to receive oral FMC-376, a novel dual inhibitor of both active and inactive KRAS G12C. Eligible patients must have ECOG 0-1.

ClinicalTrials.gov ID: NCT06244771

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 solid tumors (including NSCLC, colorectal, breast, ovarian, renal, head and neck, and urothelial carcinomas) who have progressed on or are intolerant to standard therapies, with a dose expansion cohort for advanced non-squamous NSCLC negative for common actionable mutations and previously treated with platinum chemotherapy plus PD-(L)-1 inhibitors. Patients receive AB801, an oral selective AXL inhibitor, as monotherapy or in combination with docetaxel.

ClinicalTrials.gov ID: NCT06120075

A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic 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.

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 adults with metastatic, measurable solid tumors (including GI, GU, breast, ovarian, endocrine tumors, NSCLC, and multiple myeloma with plasmacytomas) who have progressed after standard therapies, and treats them with autologous T-cells genetically engineered to express T-cell receptors targeting patient-specific tumor neoantigens, following lymphodepletion, with or without the addition of pembrolizumab. The investigational TCR therapy directly targets mutated or viral antigens unique to each patient’s cancer in an effort to induce durable tumor regression.

ClinicalTrials.gov ID: NCT03412877

A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 unresectable, recurrent, or metastatic solid tumors (including dedicated cohorts for melanoma post anti-PD-1 therapy and platinum-resistant ovarian cancer) to receive DF6215—a novel, half-life extended monovalent IL-2 agonist designed to selectively activate CD8+ T cells and NK cells—either alone or in combination with pembrolizumab. Participants must have ECOG 0-1, adequate organ function, and meet strict cardiac and infection criteria.

ClinicalTrials.gov ID: NCT06108479