Study of LP-300 with Carboplatin and Pemetrexed in Non-Smokers with Advanced Lung Cancer

Sponsor: Lantern Pharma Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05456256

Provider View

This clinical trial is testing whether adding LP-300 to standard chemotherapy drugs carboplatin and pemetrexed can improve outcomes for non-smokers with advanced lung adenocarcinoma. The study will compare progression-free survival and overall survival between patients receiving the combination treatment and those receiving only the standard chemotherapy.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding LP-300 to the standard chemotherapy drugs carboplatin and pemetrexed can help non-smokers with advanced lung adenocarcinoma live longer without their cancer getting worse. The trial will include 90 patients in the United States and will be conducted in multiple centers. It is an open-label study, meaning both the researchers and participants know which treatment is being given.

Description

This study is for non-smokers with advanced lung adenocarcinoma who have previously been treated with tyrosine kinase inhibitors (TKIs) but have relapsed. The trial will have two stages. In the first stage, 6 patients will receive LP-300 with carboplatin and pemetrexed to ensure it is safe. If no safety issues arise, the second stage will begin, where patients will be randomly assigned to receive either the combination of LP-300, carboplatin, and pemetrexed or just carboplatin and pemetrexed. Treatments will be given on the first day of a 21-day cycle, with 4 to 6 cycles planned. Patients may continue with pemetrexed alone if needed.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced lung adenocarcinoma that cannot be removed by surgery, with specific genetic changes.
  • Cancer must be locally advanced or have spread to other parts of the body.
  • Must be a non-smoker or have smoked less than 100 cigarettes in their lifetime. Former smokers with specific genetic changes may be eligible after consulting with the study team.
  • Previously treated with TKIs for non-small cell lung cancer but experienced progression or side effects.
  • Prior radiation therapy is allowed if there is at least one measurable tumor that hasn't been irradiated, and recovery from radiation effects is complete.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Aged 18 or older.
  • Stable brain metastases with no recent symptoms or medication use.
  • Fully recovered from any major surgery at least 30 days before joining the study.
  • Adequate blood cell counts and organ function based on specific lab tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study. Men must also agree to use contraception.
  • No other cancers in the past two years, except for certain skin or cervical cancers.
  • Willing to provide a tumor tissue sample if available.
  • Must sign informed consent before any study procedures.

Exclusion Criteria

  • Have a different type of lung cancer, such as small cell or squamous cell.
  • Cancer that started in another part of the body.
  • Have taken other investigational drugs, except for TKIs.
  • Progressed on chemotherapy or immunotherapy before switching to a TKI.
  • Taking certain medications that affect drug metabolism.
  • Recent heart problems or stroke.
  • Abnormal heart rhythm on an ECG.
  • Unstable brain metastases with recent symptoms.
  • No measurable disease that hasn't been irradiated.
  • Positive for HIV, hepatitis B, or hepatitis C.
  • Active infections or uncontrolled medical conditions.
  • Allergic to study drugs or their components.
  • Pregnant or breastfeeding.
  • Recent blood transfusions.
  • Any condition that could affect study participation or results.
  • Life expectancy of less than 3 months.

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