Clinical Trials for Non-Small Cell Lung Cancer

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF 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.

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 enrolls patients aged 16 or older with advanced or metastatic solid tumors (including brain tumors) featuring Class I/V600, II, or III BRAF alterations who have progressed after standard therapies, testing the brain-penetrant selective pan-mutant BRAF inhibitor PF-07799933 (ARRY-440) as monotherapy or in combination with binimetinib or cetuximab.

ClinicalTrials.gov ID: NCT05355701

Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma

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: Adults with oligoprogressive NSCLC, melanoma, or renal cell carcinoma (1-5 progressing sites while on or after checkpoint inhibitor therapy) are randomized to receive either standard SBRT or a PET-guided, biologically adaptive SBRT approach that uses PET/CT to guide dose escalation to metabolically active tumor regions. All participants must have lesions suitable for SBRT and ECOG performance status ≤2.

ClinicalTrials.gov ID: NCT05830058

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/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.

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: Adults with advanced or metastatic solid tumors expressing HER2 (including HER2-low), who are refractory or intolerant to standard therapies, receive the investigational HER2-targeted antibody-drug conjugate DB-1303/BNT323 (anti-HER2 IgG1 linked to a DNA topoisomerase I inhibitor) IV every 3 weeks; select cohorts also examine combinations with pertuzumab or CYP inhibitors for drug-drug interaction assessment.

ClinicalTrials.gov ID: NCT05150691

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants 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: Adults with advanced or metastatic solid tumors who have progressed on, or are not candidates for, standard therapies (including anti-PD-1 where appropriate) may be eligible for this trial of BMS-986340, an investigational anti-CCR8 monoclonal antibody targeting tumor-infiltrating regulatory T cells, given as monotherapy or in combination with nivolumab or docetaxel. Patients must have measurable disease, ECOG 0-1, and be able to undergo mandatory tumor biopsies.

ClinicalTrials.gov ID: NCT04895709

A Phase IIIb, Randomized, Multicenter, Open-label Study to Assess the Efficacy of Durvalumab Plus Tremelimumab Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for First-line Treatment in Metastatic Non-small Cell Lung Cancer Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON)

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 enrolls adults with previously untreated metastatic non-squamous NSCLC harboring STK11, KEAP1, or KRAS mutations (excluding EGFR/ALK), and randomizes them to durvalumab (PD-L1 inhibitor) plus tremelimumab (CTLA-4 antibody) with platinum-pemetrexed chemotherapy versus pembrolizumab (PD-1 inhibitor) with the same chemotherapy. Eligible patients must have ECOG 0-1 and measurable disease.

ClinicalTrials.gov ID: NCT06008093

A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study

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 enrolls patients aged 70 or older with stage IIIB-IV NSCLC, ECOG 2, and PD-L1 TPS 1-49% (without actionable mutations or chemo-radiation candidacy) to compare pembrolizumab (anti-PD-1 immunotherapy) plus platinum-based chemotherapy versus pembrolizumab alone. Both arms include pembrolizumab maintenance, with the primary outcome of overall survival.

ClinicalTrials.gov ID: NCT06096844

LUNG-IST-127: a Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab (CP) for Patients with Metastatic SqNSCLC with Disease Control Following Induction Therapy

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: Eligible patients are adults with metastatic squamous NSCLC (stage IV, ECOG 0-2) who achieved disease control after four cycles of first-line pembrolizumab, carboplatin, and (nab-)paclitaxel; these patients receive maintenance cabozantinib (a multi-kinase inhibitor targeting MET/VEGFR and others) plus pembrolizumab.

ClinicalTrials.gov ID: NCT05613413

A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)

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 enrolls adults with advanced or recurrent non-small cell lung cancer harboring MET exon 14 skipping mutations who have progressed after at least one prior systemic therapy, testing tepotinib (oral MET tyrosine kinase inhibitor) with or without ramucirumab (IV VEGFR2 inhibitor). Patients must not have prior exposure to MET or angiogenesis inhibitors and must lack other actionable mutations.

ClinicalTrials.gov ID: NCT06031688

A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)

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 enrolls adults with previously untreated advanced or metastatic non-squamous NSCLC with HER2 overexpression (no EGFR/ALK alterations), testing trastuzumab deruxtecan (HER2-directed antibody-drug conjugate) in combination with investigational bispecific checkpoint inhibitors (volrustomig [PD-1/CTLA-4] or rilvegostomig [PD-1/TIGIT]), with or without platinum chemotherapy. Patients must have good performance status and no major comorbidities.

ClinicalTrials.gov ID: NCT04686305

Phase II Trial of Lung Chemoemobolization

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: Adults with unresectable, unablatable non-small cell lung cancer or lung metastases progressing on or intolerant to systemic therapy receive transarterial chemoembolization (TACE) with intra-arterial mitomycin (alkylating cytotoxic agent), lipiodol (contrast/drug carrier), and embospheres (arterial embolic microspheres). This trial targets patients not eligible for surgery, ablation, or radiation, assessing local disease control using a locoregional approach.

ClinicalTrials.gov ID: NCT05672108