Clinical Trials for Non-Small Cell Lung Cancer

A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in 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 those with lesions amenable to intratumoral injection, to receive intratumoral tolododekin alfa (ANK-101), an anchored IL-12 conjugate that locally activates antitumor immunity, as monotherapy or in combination with cemiplimab for high-risk cutaneous squamous cell carcinoma. Patients must have progressed on or be ineligible for standard therapies.

ClinicalTrials.gov ID: NCT06171750

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic 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: Eligible patients are adults with locally advanced or metastatic solid tumors (including ovarian, endometrial, non-small cell lung, breast cancer, and mesothelioma) who have progressed after standard therapies, with cohorts defined by tumor type, platinum sensitivity, and folate receptor alpha (FRα) status. The trial investigates Rina-S (rinatabart sesutecan), a folate receptor alpha-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor, as monotherapy and in combination with carboplatin, bevacizumab, or pembrolizumab depending on cohort.

ClinicalTrials.gov ID: NCT05579366

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor 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 enrolls adults with advanced or metastatic EGFR-expressing solid tumors (including NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, or TNBC) who have progressed on or are intolerant to standard therapies, to receive JANX008—a protease-activated bispecific antibody that redirects T cells (via CD3) to target tumor cells (via EGFR), aiming to reduce off-tumor toxicity.

ClinicalTrials.gov ID: NCT05783622

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

An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Locally Advanced or Metastatic 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 incurable, locally advanced, or metastatic solid tumors (ECOG 0-1, measurable disease, no active CNS metastases), testing the investigational IL-2 pathway–targeting fusion protein etakafusp alfa (AB248) alone or with pembrolizumab. AB248 is designed to selectively activate CD8+ T cells to enhance anti-tumor immunity while minimizing toxicity.

ClinicalTrials.gov ID: NCT05653882

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

A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

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 previously untreated, advanced (stage IIIB–IV) NSCLC and high PD-L1 expression (≥50%), without actionable driver alterations, to compare cemiplimab (anti-PD-1) alone versus in combination with BNT116, an investigational mRNA-based vaccine targeting multiple NSCLC antigens. Key exclusions include never-smokers, patients with EGFR/ALK/ROS1 mutations, unstable CNS metastases, and significant autoimmune disease.

ClinicalTrials.gov ID: NCT05557591

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 1 Study of SGN-PDL1V in 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 metastatic or unresectable, PD-L1–expressing solid tumors (including NSCLC, HNSCC, esophageal SCC, TNBC, ovarian cancer, melanoma, and gastric cancer) who have failed or are ineligible for standard therapies. Patients receive either SGN-PDL1V, an antibody-drug conjugate targeting PD-L1 and delivering MMAE, or a combination of SGN-PDL1V plus pembrolizumab.

ClinicalTrials.gov ID: NCT05208762