Clinical Trials for Non-Small Cell Lung Cancer

A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated 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 solid tumors harboring a KRAS G12D mutation (including PDAC, NSCLC, and CRC) who have progressed after prior therapy, and evaluates the investigational oral KRAS G12D dual ON/OFF inhibitor VS-7375 as monotherapy and in combination with cetuximab. Key exclusions include prior KRAS G12D inhibitors and active CNS metastases.

ClinicalTrials.gov ID: NCT07020221

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated 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 solid tumors or pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation who have received prior standard therapies, testing ARV-806, an investigational IV protein degrader specifically targeting mutant KRAS G12D. Patients with prior KRAS G12D/pan-KRAS inhibitor exposure or uncontrolled comorbidities are excluded.

ClinicalTrials.gov ID: NCT07023731

A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced 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: Adults with unresectable, advanced, or metastatic NSCLC or SCLC—including both treatment-naïve and previously treated patients—are eligible for this trial evaluating BNT324, a B7-H3-targeted antibody-drug conjugate, in combination with BNT327, a bispecific antibody targeting PD-L1 and VEGF-A. Separate cohorts include NSCLC with and without actionable oncogenic alterations and both first- and later-line treatment settings.

ClinicalTrials.gov ID: NCT06892548

AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS 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 enrolls patients with advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC to receive PF-08046037, an immune-stimulating antibody-drug conjugate targeting PD-L1 and delivering a TLR7 agonist, either as monotherapy or in combination with sasanlimab (anti-PD-1). Participants must have measurable disease and available tumor tissue, with other eligibility based on prior therapies and comorbidities.

ClinicalTrials.gov ID: NCT06974734

Phase II Study of Diclofenac Salvage in Patients Metastatic Non-Small Cell Lung Cancer With Early Signs of Progression on Single Agent PD(L)-1 Blockade

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: Enrolling adults with stage III or IV metastatic non-small cell lung cancer who are experiencing early radiographic progression on at least 12 weeks of single-agent PD-1 or PD-L1 inhibitor immunotherapy, this trial adds diclofenac (a cyclooxygenase-inhibiting NSAID with potential immunomodulatory effects) to ongoing checkpoint inhibitor therapy. Patients must have adequate organ function, ECOG 0-2, and no contraindications to NSAIDs or need for anticoagulation.

ClinicalTrials.gov ID: NCT06731270

An Open-Label Phase 1 Study to Evaluate PF-08046032 as Monotherapy and Part of Combination Therapy in Participants 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 enrolls adults with advanced or metastatic malignancies—including relapsed/refractory Hodgkin lymphoma, certain non-Hodgkin lymphomas, and selected solid tumors—who meet specific prior treatment criteria, to receive PF-08046032, an investigational CD25-targeting antibody-drug conjugate designed to deplete tumor-infiltrating Tregs, as monotherapy or in combination with the anti-PD-1 antibody sasanlimab. Key exclusions are active autoimmune disease, significant prior immune toxicity, or ongoing neuropathy.

ClinicalTrials.gov ID: NCT06870487

A Study of PARG Inhibitor IDE161 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies 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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors (select cohorts: 2L+ cutaneous melanoma, EGFR-mutated or EGFR/ALK/ROS1–negative NSCLC, rare melanomas, other solid tumors; and in combination: 2L+ melanoma and HER2‑negative metastatic breast cancer) receive the HER3-targeting antibody–drug conjugate BNT326 (topoisomerase I payload) as monotherapy or combined with BNT327, a bispecific anti–PD-L1/anti–VEGF-A antibody. Includes a dedicated drug–drug interaction cohort with CYP inhibitors (itraconazole or paroxetine).

ClinicalTrials.gov ID: NCT07070232

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)

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: Adults with advanced/metastatic EGFR-mutant NSCLC (ex19del/L858R), ECOG 0–1, after prior EGFR TKI; Part B requires C797X resistance mutation. Single‑agent DZD6008, an oral fourth‑generation, mutant‑selective EGFR TKI with designed activity against C797X (including C797S) and CNS penetration, is given once daily with dose escalation then expansion.

ClinicalTrials.gov ID: NCT06905197

Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1

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: Single-arm study for adults with newly diagnosed advanced/metastatic NSCLC with PD-L1 ≥1% and no prior metastatic systemic therapy, testing intravenous trabedersen (OT-101)—an antisense oligonucleotide targeting TGF-β2 to reduce tumor immune suppression—combined with fixed-dose pembrolizumab. Phase 1 identifies the RP2D of OT-101 (4-days-on/10-days-off IV schedule) with pembrolizumab Q6W, followed by phase 2 assessing efficacy.

ClinicalTrials.gov ID: NCT06579196