LP-300 with Chemotherapy for Advanced Lung Adenocarcinoma in Never Smokers

This study is testing a new combination treatment for advanced lung adenocarcinoma (a type of lung cancer) in people who have never smoked. It combines a drug called LP-300 with standard chemotherapy drugs, carboplatin and pemetrexed. The goal is to see if adding LP-300 improves how long patients live without their cancer getting worse (progression-free survival) and how long they live overall (overall survival). You may be able to join if you have advanced lung adenocarcinoma, have never smoked, and your cancer has specific genetic changes (like ALK, EGFR, or MET mutations). The study is currently recruiting patients in the United States.

Study design
This is a multi-center, open-label (meaning you and your doctors will know what treatment you are receiving) Phase 2 study. It plans to enroll 90 patients and will compare the LP-300 combination to standard chemotherapy alone.
What's involved
You would receive LP-300, carboplatin, and pemetrexed by IV infusion every 21 days for 4 to 6 cycles. After these cycles, you might continue pemetrexed maintenance therapy.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed through study completion, which is an average of 2 years.

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NCT05456256

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Lantern Pharma Inc.
~90 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:LP-300PemetrexedCarboplatin

At a glance

Recruiting sites
10 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over Through study completion, an average of 2 years
+1 more outcome measured
Adenocarcinoma of Lung
Carcinoma, Non-Small-Cell Lung
16 sites across 10 states
Taiwan5
California3
Pennsylvania1
Texas1
Virginia1
Hokkaido1
Kanagawa1
Miyagi1
  • Reggie Ewesuedo, MD · STUDY_DIRECTOR · Lantern Pharma Inc.

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Eligibility criteria

Inclusion

White blood cell count ≥ 2 x 10\*9/L
Absolute neutrophil count (ANC) ≥ 1.5 x 10\*9/L
Hemoglobin ≥ 10 g/dL
Platelet count ≥ 100 x 10\*9/L
Total bilirubin \< 1.5 x the upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin \< 2.5 x ULN
Aspartate aminotransferase/ serum glutamic oxaloacetic transaminase (AST/SGOT) ≤ 2.5 x ULN
Alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
Alkaline phosphatase ≤ 2.5 x ULN
Baseline serum creatinine level no greater than 1.5 mg/dL or 133 μmol/L.
Creatinine clearance ≥ 45 mL/min as calculated using the Cockcroft-Gault methodology (Cockcroft 1976)
Magnesium ≥ 1.7 mg/dL 11. Female patients of child-bearing potential must have a negative pregnancy test and must agree to use an acceptable contraceptive method during the study and for 12 weeks after their last dose of study treatment. Male patients with partners of child-bearing potential must also agree to use an adequate method of contraception for the duration of the study and for 12 weeks after their last dose of study treatment.
Curatively-treated basal cell carcinoma,
Ductal carcinoma in situ (DCIS) of the breast
Non-melanomatous carcinoma of the skin, or
Carcinoma in situ of the cervix. 13. Be willing to provide an archival tumor tissue sample, if available. The archival sample must be from a tumor lesion that was not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. The sample must have been obtained less than 36 months prior to consent. 14. Provide signed, written, Institutional Review Board (IRB) approved informed consent prior to any screening procedures.
  • Progression-free survival (PFS)Through study completion, an average of 2 years

    Number of days or months from the date of randomization to the earliest of the documented disease progression based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria

  • Overall survival (OS)Through study completion, an average of 2 years

    Number of days or months between the randomization date and the date of death from all causes