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Alkylating agents

LP-300 + Chemotherapy for Lung Adenocarcinoma (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

HARMONIC Trial Summary

This trial is testing a new cancer drug combo to see if it's more effective than the current standard of care, in patients who have never smoked.

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.Check my eligibility
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.See study design
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.

HARMONIC Trial 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:

HARMONIC Trial 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

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

HARMONIC 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
Carboplatin
FDA approved
Pemetrexed
FDA approved

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: LP-300 in Combination with Pemetrexed and Carboplatin, Pemetrexed and Carboplatin (Standard of Care)
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor taking on new participants presently?

"Data on clinicaltrials.gov indicates that recruitment for this medical trial is currently underway, with the initial posting being made on August 12th 2022 and most recent update occurring 16 days later."

Verified Answer

How many individuals are being included as part of this research endeavor?

"Indeed, the information on clinicaltrials.gov confirms this trial is still recruiting candidates. It was first published on August 12th 2022 and revised most recently on September 16th 2022. The investigators are seeking 90 volunteers to participate in this study at two distinct sites."

Verified Answer

Has the FDA authorized LP-300 as a treatment option?

"LP-300's safety rating stands at 2 due to the Phase 2 trial data, which has not yet shown efficacy but does offer evidence of its security."

Verified Answer

Who else is applying?

What state do they live in?
Kansas
What site did they apply to?
Texas Oncology-Charles A. Sammons Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Most responsive sites:
  1. Texas Oncology-Charles A. Sammons Cancer Center: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
~24 spots leftby Nov 2024