Clinical Trials for Non-Small Cell Lung Cancer

Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)

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.

TrialFetch AI summary: This trial enrolls adults with stage IV or recurrent NSCLC harboring EGFR, ALK, ROS1, or HER2 alterations, who have progressed after appropriate targeted and systemic therapy (excluding prior PD-1/PD-L1 inhibitors). Patients receive CD40L-augmented tumor-infiltrating lymphocytes (TILs), which are designed to enhance T-cell activation, in combination with nivolumab following lymphodepleting chemotherapy and interleukin-2 support.

ClinicalTrials.gov ID: NCT05681780

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.

TrialFetch 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

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.

TrialFetch AI summary: Adults with advanced or metastatic breast, non-small-cell lung, gastric/gastroesophageal, or colorectal cancer who have progressed on, cannot tolerate, or cannot access standard therapy receive intravenous DM001 every 3 weeks. DM001 is an investigational bispecific antibody–drug conjugate targeting TROP2 and EGFR that delivers a topoisomerase I inhibitor payload.

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.

TrialFetch AI summary: Adults with KRAS G12C-mutated locally advanced unresectable or metastatic solid tumors who have progressed on or cannot receive standard therapy receive oral FMC-376, an investigational inhibitor designed to covalently target both active and inactive KRAS G12C.

ClinicalTrials.gov ID: NCT06244771

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.

TrialFetch 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

Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).

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.

TrialFetch AI summary: Adults with unresectable stage IIIB/C or IV EGFR exon 19 deletion– or L858R-mutant NSCLC that progressed on a third-generation EGFR TKI receive oral STX-241 twice daily; backfill and dose-optimization cohorts require an acquired C797X mutation without T790M. STX-241 is an investigational, CNS-penetrant, reversible EGFR inhibitor designed to target C797X-containing mutants while sparing wild-type EGFR.

ClinicalTrials.gov ID: NCT06567015

An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-112 in Human Leukocyte Antigen-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for the KRAS G12D Mutation

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.

TrialFetch AI summary: Adults with HLA-C*08:02-positive, KRAS G12D-mutant unresectable advanced or metastatic solid tumors who have received at least one approved systemic regimen and have no curative option receive a single infusion of NT-112, an autologous TCR-engineered T-cell therapy targeting KRAS G12D presented by HLA-C*08:02. Treatment includes lymphodepletion before infusion and a short course of interleukin-2 afterward.

ClinicalTrials.gov ID: NCT06218914

An Open-label Phase 1 Study to Investigate SGN-CEACAM5C 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.

TrialFetch AI summary: Adults with relapsed, refractory, or progressive unresectable or metastatic solid tumors, including colorectal, gastric/gastroesophageal junction, pancreatic, and lung cancers, receive PF-08046050, a CEACAM5-targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor. Previously treated colorectal adenocarcinoma cohorts receive PF-08046050 with bevacizumab.

ClinicalTrials.gov ID: NCT06131840

Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant 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.

No known activity

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

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic KRAS G12C-mutant NSCLC who have progressed after anti–PD-(L)1 therapy, with or without platinum chemotherapy, and have not received a KRAS inhibitor receive sotorasib plus investigational ladarixin. Ladarixin inhibits CXCR1/CXCR2 signaling; sotorasib inhibits KRAS G12C.

ClinicalTrials.gov ID: NCT05815173

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy 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.

TrialFetch AI summary: Adults with metastatic solid tumors, measurable disease, and ECOG performance status 0–1 receive intravenous MDX2001 monotherapy. MDX2001 is an investigational tetraspecific antibody that binds c-MET and TROP2 on tumors while engaging CD3 and providing CD28 costimulation to promote tumor-directed T-cell activity.

ClinicalTrials.gov ID: NCT06239194