Clinical Trials for Non-Small Cell Lung Cancer

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

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: This trial investigates DF1001, a tri-specific NK cell engager targeting HER2-expressing tumors, in patients with locally advanced or metastatic solid tumors including HER2-activated non-small cell lung cancer and breast, gastric, esophageal, and urothelial bladder cancers, as monotherapy or combined with treatments like nivolumab, Nab-paclitaxel, and Sacituzumab govitecan-hziy.

ClinicalTrials.gov ID: NCT04143711

A Phase 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients 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.

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 evaluates CHS-388, a monoclonal antibody targeting IL-27 to reduce immunosuppression, as both monotherapy and in combination with pembrolizumab and toripalimab, in adult patients with advanced ccRCC, HCC, or NSCLC who have progressed after standard treatments. It focuses on those with limited treatment options, assessing safety and preliminary efficacy across different treatment arms based on previous therapies and tumor types.

ClinicalTrials.gov ID: NCT04374877

Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other 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.

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 evaluates MCLA-129, a bispecific antibody targeting EGFR and c-MET, administered alone or with osimertinib or chemotherapy, in patients with advanced NSCLC, GC/GEJ, HNSCC, and ESCC who progressed after standard treatments or possess relevant genetic mutations. Participants require measurable disease, ECOG status 0 or 1, and a life expectancy of at least 12 weeks.

ClinicalTrials.gov ID: NCT04868877

Phase I/II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant 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.

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 involves adults with advanced solid tumors resistant to PD-(L)1 inhibitors, using RAPA-201, an investigational immunotherapy leveraging autologous T cells engineered for temsirolimus resistance and favorable immune traits, combined with the chemotherapy regimen of carboplatin and paclitaxel.

ClinicalTrials.gov ID: NCT05144698

A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer

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: The trial evaluates the combination of quaratusugene ozeplasmid, a systemic gene therapy encapsulating the TUSC2 tumor suppressor gene, with osimertinib in patients aged 18 and over with EGFR-mutant, metastatic Non-Small Cell Lung Cancer (NSCLC) who have progressed after at least four months on osimertinib. This combination targets cells with EGFR mutations, offering a potential treatment option compared to standard platinum-based chemotherapy.

ClinicalTrials.gov ID: NCT04486833

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)

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: This trial investigates TSR-022, a TIM-3 checkpoint inhibitor, as monotherapy or in combination with therapies such as anti-PD-1 drugs in adult patients with advanced or metastatic solid tumors, including NSCLC and HCC, who have previously been treated with standard therapies. Eligible patients should have measurable disease and agree to biopsies for TIM-3 expression assessment.

ClinicalTrials.gov ID: NCT02817633

Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With 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: This trial involves Black patients aged 18 or older with advanced/metastatic NSCLC without EGFR/ALK/ROS1 mutations, assessing pembrolizumab (a PD-1 inhibitor) alone or with chemotherapy, across different cohorts based on PD-L1 status and ctDNA levels, to evaluate survival and response outcomes.

ClinicalTrials.gov ID: NCT06745882

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

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: This trial involves adult patients with relapsed or metastatic solid tumors who have received prior standard treatments or are best suited for a clinical trial, assessing AZD8205, an investigational ADC targeting B7-H4, both as a monotherapy and in combination with rilvegostomig and saruparib. Participants must have measurable disease, an ECOG status of 0-1, and a life expectancy of at least 12 weeks.

ClinicalTrials.gov ID: NCT05123482

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

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: This trial targets adults with breast cancer or NSCLC with leptomeningeal metastases, using craniospinal irradiation with hippocampal avoidance via proton or VMAT to reduce neurological side effects while effectively treating the cancer. Participants require a KPS of ≥ 60 and suitable blood counts, and treatment is given over two weeks.

ClinicalTrials.gov ID: NCT06518057

Phase II Feasibility Study of Healthy Donor FMT (hdFMT) and Pembrolizumab in Relapsed/Refractory (R/R) PD-L1 Positive 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: This trial involves patients with stage IV PD-L1 positive NSCLC that progressed after at least two doses of anti-PD-1/PD-L1 therapy, excluding specific cancer subtypes, and explores the efficacy and safety of combining healthy donor fecal microbiota transplants (hdFMT) with pembrolizumab, a PD-1 inhibitor.

ClinicalTrials.gov ID: NCT05669846