Clinical Trials for Non-Small Cell Lung Cancer

UCDCC#272: A Phase I/II Study of Intralesional IL-2, Hypofractionated Radiotherapy, and Pembrolizumab in Patients Refractory to Standard-of-Care PD-1/PD-L1 Checkpoint Blockade

TrialFetch AI summary: The trial targets patients with metastatic NSCLC, melanoma, RCC, or HNSCC who are resistant to standard PD-1/PD-L1 checkpoint inhibitors, evaluating the combination of pembrolizumab, intralesional IL-2, and hypofractionated radiotherapy to stimulate an immune response. Pembrolizumab acts as a PD-1 inhibitor, while IL-2 is used for local immune activation, and radiotherapy is applied to enhance systemic antitumor effects.

ClinicalTrials.gov ID: NCT03474497

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.

TrialFetch 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.

TrialFetch 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

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

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.

TrialFetch AI summary: This trial compares proton craniospinal irradiation (pCSI) versus involved-field radiotherapy (IFRT) in adult patients with leptomeningeal metastasis from breast cancer or non-small cell lung cancer, focusing on overall survival and other CNS outcomes.

ClinicalTrials.gov ID: NCT06500481

A Phase Ib Study of Vismodegib and Atezolizumab in Patients with Advanced Non-Small Cell Lung Cancer (ML43922)

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.

TrialFetch AI summary: The trial targets patients aged 18 and older with recurrent or metastatic non-small cell lung cancer who have exhausted curative treatments, investigating a combination of vismodegib, an inhibitor of the Hedgehog signaling pathway, and atezolizumab, a PD-L1 immune checkpoint inhibitor. Participants must have measurable disease and will receive treatment in a non-randomized, open-label single arm to evaluate safety, tolerability, and efficacy.

ClinicalTrials.gov ID: NCT06616623

Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer

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.

TrialFetch AI summary: This trial targets vulnerable or older adults aged 70 or above with advanced non-small cell lung cancer (NSCLC) and a PD-L1 TPS of less than 50%, assessing the safety and efficacy of reduced dose chemotherapy with carboplatin and paclitaxel or pemetrexed (depending on histology), in combination with Pembrolizumab, an anti-PD-1 antibody therapy.

ClinicalTrials.gov ID: NCT06731413

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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.

TrialFetch AI summary: This trial enrolls patients with previously untreated, locally advanced or metastatic non-squamous NSCLC with a documented KRAS G12C mutation, randomizing them to receive adagrasib (a selective KRAS G12C inhibitor) plus pembrolizumab and platinum-pemetrexed chemotherapy versus placebo plus pembrolizumab and chemotherapy. Patients may have asymptomatic, untreated brain metastases ≤ 20 mm; prior KRAS G12C inhibitor therapy is not allowed.

ClinicalTrials.gov ID: NCT06875310

LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced 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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic NSCLC—including those post standard therapies, unresectable stage III after chemoradiotherapy, and resectable stage II/III eligible for perioperative treatment—and investigates BNT116, an mRNA cancer vaccine targeting six NSCLC antigens, as monotherapy or combined with standard chemotherapy, PD-1/CTLA-4 inhibition (cemiplimab, BNT316), and antibody–drug conjugates. Eligibility generally excludes patients with targetable mutations for which approved therapies exist.

ClinicalTrials.gov ID: NCT05142189

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected 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.

TrialFetch AI summary: This trial enrolls adults with advanced solid tumors—including specific expansion cohorts for RCC, NSCLC, and PD-L1-negative NSCLC—who have progressed after or cannot tolerate standard therapies or are treatment naïve for metastatic disease without actionable mutations. Patients receive STK-012, an engineered IL-2 partial agonist that selectively stimulates CD25+ T cells with reduced toxicity risk, as monotherapy or in combination with pembrolizumab, and in NSCLC, with pembrolizumab plus pemetrexed and carboplatin.

ClinicalTrials.gov ID: NCT05098132

A First-In-human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Administered by Parenteral Route in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3

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.

TrialFetch AI summary: This trial enrolls adults with advanced, DLL3-positive small cell lung cancer, large cell neuroendocrine lung carcinoma, or neuroendocrine carcinoma of any origin who have progressed after standard therapies, to receive BI 764532—a parenterally administered DLL3/CD3 bispecific T-cell engager antibody. Eligible patients must have good performance status and adequate organ function, and may include those with treated or stable brain metastases.

ClinicalTrials.gov ID: NCT04429087