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Alkylating agents

LP-300 + Chemotherapy for Lung Adenocarcinoma EGFR (HARMONIC Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Lantern Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you ever been treated with an immunotherapy?
Has your disease progressed despite treatment?
Must not have
Have you ever been a smoker?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial tests a new drug, LP-300, combined with two existing chemotherapy drugs in never smokers with a specific type of lung cancer who did not respond to previous treatments. The goal is to see if this combination improves survival by making the chemotherapy more effective.

Who is the study for?
This trial is for never smokers over 18 with advanced lung adenocarcinoma, including those who've had TKI treatment but now show disease progression or can't tolerate TKIs. Participants must have stable CNS metastases, adequate organ function, and no recent serious cardiovascular events. They should not be HIV or hepatitis positive and must agree to use contraception.
What is being tested?
The study tests the effectiveness of LP-300 combined with carboplatin and pemetrexed chemotherapy in improving survival without cancer progression compared to just chemotherapy alone. It's an open-label phase II trial involving 90 patients across multiple U.S. centers.
What are the potential side effects?
Potential side effects may include reactions related to chemotherapy such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, kidney issues from carboplatin, and possible allergic reactions to any of the drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival (OS)
Progression-free survival (PFS)
Secondary study objectives
Clinical benefit rate (CBR)
Duration of objective response (DOR)
Objective response rate (ORR)

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LP-300 in Combination with Pemetrexed and CarboplatinExperimental Treatment3 Interventions
LP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.
Group II: Pemetrexed and Carboplatin (Standard of Care)Active Control2 Interventions
Pemetrexed and Carboplatin Only (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Carboplatin
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy agents such as carboplatin and pemetrexed. Carboplatin works by forming cross-links in DNA, which inhibits DNA replication and leads to cell death. Pemetrexed disrupts folate-dependent metabolic processes essential for cell replication. The investigational agent LP-300 is believed to enhance the efficacy of these chemotherapy drugs by modulating oxidative stress and improving drug delivery to cancer cells. This is particularly important for NSCLC patients as it may lead to better treatment outcomes by increasing the effectiveness of standard chemotherapy regimens.

Find a Location

Who is running the clinical trial?

Lantern Pharma Inc.Lead Sponsor
3 Previous Clinical Trials
167 Total Patients Enrolled
Reggie Ewesuedo, MDStudy DirectorLantern Pharma Inc.
2 Previous Clinical Trials
140 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05456256 — Phase 2
Lung Adenocarcinoma Research Study Groups: Pemetrexed and Carboplatin (Standard of Care), LP-300 in Combination with Pemetrexed and Carboplatin
Lung Adenocarcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05456256 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456256 — Phase 2
~0 spots leftby Nov 2024