OncoMatch/Clinical Trials/NCT05456256
A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma
Is NCT05456256 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including LP-300 and Pemetrexed for adenocarcinoma of lung.
Treatment: LP-300 · Pemetrexed · Carboplatin — The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MET exon 14 skipping mutation
MET exon14 skipping mutations
Required: ALK fusion
anaplastic lymphoma kinase (ALK)
Required: EGFR mutation
epidermal growth factor receptor (EGFR)
Required: NTRK1 fusion
neurotrophic tyrosine receptor kinase (NTRK) fusions
Required: NTRK2 fusion
neurotrophic tyrosine receptor kinase (NTRK) fusions
Required: NTRK3 fusion
neurotrophic tyrosine receptor kinase (NTRK) fusions
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: tyrosine kinase inhibitor — non-small cell lung cancer
Patients who have received systemic treatment with tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer but have experienced disease progression, unacceptable TKI-related toxicities, or are unable to tolerate the further use of TKIs.
Cannot have received: chemotherapy and/or immunotherapy
Exception: allowed if transitioned to a TKI with no evidence of disease progression
Patients who experienced disease progression while on chemotherapy and/or immunotherapy will be ineligible for the trial.
Cannot have received: investigational agents
Exception: except for investigational TKI drugs
Patients who have received any prior investigational agents except for investigational TKI drugs.
Lab requirements
Blood counts
White blood cell count ≥ 2 x 10^9/L; ANC ≥ 1.5 x 10^9/L; Hemoglobin ≥ 10 g/dL; Platelet count ≥ 100 x 10^9/L; Magnesium ≥ 1.7 mg/dL
Kidney function
Baseline serum creatinine ≤ 1.5 mg/dL or 133 μmol/L; Creatinine clearance ≥ 45 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin < 1.5 x ULN (or < 2.5 x ULN for Gilbert's syndrome); AST/SGOT ≤ 2.5 x ULN; ALT/SGPT ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN
Cardiac function
QTcF ≤ 470 msec (average of triplicate ECGs) at Screening and/or on C1D1 (pre-dose) except for a documented bundle branch block or unless secondary to pacemaker
adequate bone marrow, adequate hepatic function, and baseline creatinine levels documented by specific laboratory criteria within 21 days prior to enrollment, including the following: ... QTcF ≤ 470 msec (average of triplicate ECGs) at Screening and/or on C1D1 (pre-dose) except for a documented bundle branch block or unless secondary to pacemaker
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Precision NextGen Oncology and Research Center · Beverly Hills, California
- Los Angeles Cancer Network · Fountain Valley, California
- Cancer and Blood Specialists Clinic · Los Alamitos, California
- Fox Chase Cancer Center · Philadelphia, Pennsylvania
- UT Southwestern Medical Center · Dallas, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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