Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects 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 includes adult patients with relapsed or refractory advanced solid tumors, such as non-small cell lung cancer, renal cell carcinoma, and head and neck squamous cell carcinoma, who have an ECOG performance status of 0 or 1. It evaluates the safety and efficacy of ABBV-303, a trispecific killer cell engager targeting c-Met, as monotherapy and in combination with budigalimab, a PD-1 inhibitor.

ClinicalTrials.gov ID: NCT06158958

A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 BDTX-1535, an oral, brain-penetrant, irreversible EGFR inhibitor, in adult patients with advanced/metastatic NSCLC with specific resistance EGFR mutations and GBM patients with EGFR alterations, assessing its safety, dosage, CNS activity, and efficacy.

ClinicalTrials.gov ID: NCT05256290

A Phase 1, Multicenter, Open-label, First-in-human Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast 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.

HealthScout AI summary: This trial involves the antibody-drug conjugate YL202, targeting the HER3 protein and delivering a cytotoxic topoisomerase I inhibitor, in patients with locally advanced or metastatic EGFR-mutated NSCLC or hormone receptor-positive, HER2-negative breast cancer who have undergone prior standard treatments. The study focuses on evaluating the safety and early efficacy through varying dosages of YL202.

ClinicalTrials.gov ID: NCT05653752

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer 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.

HealthScout AI summary: This trial involves patients with metastatic or unresectable non-small cell lung cancer and other solid tumors who receive BL-B01D1, a bispecific antibody-drug conjugate targeting EGFR and HER3, designed with a novel topoisomerase I inhibitor payload. The study evaluates different dosing schedules to determine safety, tolerability, and efficacy, particularly aiming to optimize dosing based on promising response rates in EGFR-mutated NSCLC and other cancer types.

ClinicalTrials.gov ID: NCT05983432

Phase 1b/2a Safety and Tolerability Study of Bemcentinib With Pembrolizumab/Carboplatin/Pemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Without/With a STK11 Mutation

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 involves patients with untreated advanced or metastatic non-squamous NSCLC, including those with an STK11 mutation, receiving bemcentinib—a selective AXL receptor tyrosine kinase inhibitor—alongside pembrolizumab, carboplatin, and pemetrexed to evaluate safety, tolerability, and antitumor activity.

ClinicalTrials.gov ID: NCT05469178

A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab in Patients With Immune Checkpoint Inhibitor Refractory 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.

HealthScout AI summary: The trial investigates the safety and tolerability of TILT-123, an oncolytic adenovirus encoding TNF-alpha and IL-2, in combination with Pembrolizumab, for adult patients with non-small cell lung cancer refractory to immune checkpoint inhibitors, aiming to stimulate anti-tumor immune responses and establish the Maximum Tolerated Dose.

ClinicalTrials.gov ID: NCT06125197

Phase I/II Study Exploring the Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 the combination of the investigational drug APL-101, a selective c-MET inhibitor, with standard osimertinib therapy in adults with EGFR-mutated metastatic NSCLC, focusing on those who have been on osimertinib for 8 to 16 weeks without disease progression. The study aims to establish the maximum tolerated dose and assess progression-free survival and objective response rate.

ClinicalTrials.gov ID: NCT04743505

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination With Docetaxel in Participants With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation

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 involves patients with advanced or metastatic solid tumors with SMARCA4 mutations, evaluating the investigational drug PRT3789, a novel SMARCA2 degrader, as monotherapy or combined with docetaxel. The study aims to determine the safety, tolerability, and optimal dosing, focusing on PRT3789's selective targeting mechanism to exploit synthetic lethality.

ClinicalTrials.gov ID: NCT05639751

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies

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 involves adult patients with advanced solid tumors, including those with platinum-resistant ovarian cancer or cutaneous squamous cell carcinoma, assessing the safety and efficacy of OR502, a monoclonal antibody targeting LILRB2 on tumor-associated macrophages, alone and with cemiplimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT06090266

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant 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 involves patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations and evaluates the safety and efficacy of ORIC-114, a selective irreversible inhibitor targeting EGFR exon 20 mutations, in combination with amivantamab, a bispecific EGFR and MET receptor-directed antibody.

ClinicalTrials.gov ID: NCT06816992