What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapies, and radiation therapy. Chemotherapy agents like carboplatin and paclitaxel can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered blood cell counts. Targeted therapies, such as RET inhibitors (e.g., selpercatinib), may lead to hypertension, liver enzyme abnormalities, and hyponatremia. Radiation therapy can result in esophagitis, pneumonitis, and fatigue. These side effects vary in severity and frequency depending on the specific treatment regimen and patient factors.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include a variety of targeted therapies, immunotherapies, and chemotherapies. Targeted therapies such as osimertinib for EGFR mutations, crizotinib for ALK rearrangements, and sotorasib for KRAS G12C mutations have been approved. Immunotherapies like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways, are also commonly used. Chemotherapy agents such as pemetrexed and docetaxel are standard treatments. While specific information on treatments similar to the dose-escalation study of Rhenium Re 188 P2045 is limited, the general approach of determining maximum tolerated doses through phase I trials is a common method in the development of these therapies.

What other types of research exist?

Promising novel alternatives for NSCLC patients in 2024 include: 1) Entrectinib for ROS1 fusion-positive NSCLC, which has shown efficacy in clinical trials. 2) Alectinib for RET-rearranged NSCLC, which has demonstrated safety and efficacy in phase 1/2 studies. 3) Lutetium Lu 177 vipivotide tetraxetan, particularly for patients previously treated with Ra-223, showing clinical efficacy in ongoing studies. These alternatives offer targeted therapy options based on specific genetic markers and prior treatment history.

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Radioisotope Therapy

Rhenium Re 188 P2045 for Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Andarix Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically or cytologically documented Non-Small-Cell Lung Cancer (NSCLC) or Small-Cell Lung Cancer (SCLC) and has advanced or recurrent IIIb or IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell, mixed or not otherwise specified) or disseminated or recurrent SCLC or any lung cancer which has local recurrence

Has documentation of progressive disease following prior chemotherapy or who refused to receive standard chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year post study completion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called Rhenium Re 188 P2045 on lung cancer patients. It aims to find a safe dose and check if it helps reduce tumors. Patients are monitored closely for side effects and tumor response.

Who is the study for?

This trial is for adults with advanced or recurrent lung cancer (NSCLC or SCLC) who have seen their disease progress after chemotherapy, or those who refused standard chemo. They must have a measurable tumor that hasn't been treated with radiation, or one that has grown significantly if previously irradiated.

What is being tested?

The study is testing the safety of different doses of an experimental drug called Rhenium Re 188 P2045 in lung cancer patients. The goal is to find the highest dose patients can take without serious side effects by starting low and gradually increasing.

What are the potential side effects?

Since Rhenium Re 188 P2045 is experimental, specific side effects are being studied. However, potential risks may include typical reactions to new cancer drugs such as nausea, fatigue, allergic reactions, and possibly others determined during the trial.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is advanced, recurrent, or has spread.

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My cancer has worsened after chemotherapy or I chose not to undergo standard chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year post study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year post study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year post study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose of Rhenium 188 P2045

Progression free survival in treated patients

Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

0 / 2Eligibility 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, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, but it can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target genetic mutations or proteins that drive cancer growth, offering a more personalized treatment approach with potentially fewer side effects. Immunotherapy, including immune checkpoint inhibitors, boosts the body's immune system to recognize and attack cancer cells. Understanding these mechanisms is crucial for NSCLC patients as it helps in selecting the most effective treatment with manageable side effects, and dose-escalation studies like those involving Rhenium Re 188 P2045 are essential for optimizing treatment efficacy and safety.

Radiation Dose Escalation in Stage III Non-Small-Cell Lung Cancer.Management of unresectable stage III non-small-cell lung cancer with combined-modality therapy: a review of the current literature and recommendations for treatment.