What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy agents such as carboplatin and pemetrexed. The known side effects of carboplatin include hematologic toxicities like neutropenia, thrombocytopenia, and anemia, as well as non-hematologic toxicities such as nausea, vomiting, and nephrotoxicity. Pemetrexed can cause myelosuppression, fatigue, rash, and gastrointestinal disturbances. When combined, these agents may also lead to increased risk of infection, mucositis, and peripheral neuropathy. The addition of LP-300 aims to enhance the efficacy of these treatments by modulating oxidative stress and improving drug delivery, potentially altering the side effect profile.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include several chemotherapy regimens and targeted therapies. Notably, carboplatin and pemetrexed are commonly used chemotherapy agents for NSCLC. Additionally, immune checkpoint inhibitors like atezolizumab and pembrolizumab have been approved for use in combination with chemotherapy, showing improved overall survival and progression-free survival in patients. These treatments aim to enhance the efficacy of chemotherapy, similar to the potential role of LP-300 in modulating oxidative stress and improving drug delivery.

What other types of research exist?

<ol> <li>Tyrosine kinase inhibitor conjugated quantum dots (QD-OSI 420) - Enhances cytotoxicity and reduces tumor volume in NSCLC models by improving intracellular drug delivery.</li> <li></li> </ol> PEG-hemoglobin - Enhances tumor oxygenation and response to chemotherapy, potentially reducing lung metastases. 3. Pegylated liposomal mitomycin C prodrug (PL-MLP) - Shows improved tolerance and efficacy in advanced solid tumors, which may be applicable to NSCLC.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

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)

+1 more

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

0 / 5Eligibility criteria met

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.