Rhenium Re 188 P2045 for Lung Cancer

Recruiting at 1 trial location

Overseen By For trial location information Andarix

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Andarix Pharmaceuticals

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the drug Rhenium Re 188 P2045 unique for lung cancer treatment?

Rhenium Re 188 P2045 is unique because it involves a radioactive isotope, Rhenium-188, which is not commonly used in standard lung cancer treatments. This drug may offer a novel approach by directly targeting cancer cells with radiation, potentially providing a different mechanism of action compared to traditional chemotherapy drugs. ^{1 2 3 4 5}

Research Team

Andarix Study Director

Principal Investigator

Andarix Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

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

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

My tumor is at least 1 cm big in a non-radiated area or has grown 50% in a radiated area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of Rhenium Re 188 P2045 to determine the maximum tolerated dose

4 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits for safety assessments and tumor progression analysis

Treatment Details

Interventions

• Rhenium Re 188 P2045

Trial Overview 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.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Andarix Pharmaceuticals

Lead Sponsor

Trials

1

Recruited

60+

Findings from Research

Irinotecan, a topoisomerase I inhibitor, showed a promising 32% response rate in a phase II study for non-small-cell lung cancer, and when combined with cisplatin, the response rate increased to 54% in a phase I trial.

In stage IV non-small-cell lung cancer patients, the combination of irinotecan and cisplatin provided a significant survival advantage, with a median survival time of 50 weeks compared to 36.4 weeks for vindesine/cisplatin, indicating potential benefits of this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of the standard regimen for non-small-cell lung cancer in Japan. Masuda, N.[2018]

Current standard treatment for advanced non-small-cell lung cancer involves doublet chemotherapy, which has shown 1-year survival rates of approximately 35% and 2-year survival rates of about 15%.

Preliminary studies indicate that triplet therapy may enhance survival rates compared to double therapy, with toxicity rates being low enough to support the development of these three-drug combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triplet combination chemotherapy and targeted therapy regimens. Bunn, PA.[2005]

Cisplatin-based chemotherapy has shown a modest survival benefit in patients with locally advanced, inoperable non-small cell lung cancer when combined with radiation therapy, potentially doubling or tripling long-term survival rates despite only a modest improvement in median survival.

While there is some evidence supporting the use of cisplatin-based chemotherapy as an adjuvant treatment after surgery for operable lung cancer, results are mixed, and further studies are needed to clarify its effectiveness compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of non-small cell lung cancer: current perspectives and controversies, future directions. Bunn, PA.[2007]

Cisplatin-based chemotherapy is preferred for treating advanced nonsmall cell lung cancer, with carboplatin as an alternative for patients with contraindications; nonplatinum regimens are also available for those who cannot tolerate platinum-based treatments.

There is no evidence that higher doses of cisplatin improve survival compared to standard doses, and a minimum of four to six cycles of chemotherapy is recommended for patients who respond well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First- and second-line therapy for advanced nonsmall cell lung cancer. Sculier, JP., Moro-Sibilot, D.[2018]

In a phase II study involving 39 patients with completely resected stage II or III non-small cell lung cancer, 92.3% completed four cycles of adjuvant chemotherapy with nedaplatin and irinotecan, indicating high tolerability of this regimen.

The treatment resulted in a median disease-free survival of 49.4 months and a 5-year overall survival rate of 69.8%, suggesting that nedaplatin and irinotecan are effective options for improving outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of nedaplatin and irinotecan as adjuvant chemotherapy for completely resected non-small cell lung cancer. Murakami, S., Saito, H., Kondo, T., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Establishment of the standard regimen for non-small-cell lung cancer in Japan. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Triplet combination chemotherapy and targeted therapy regimens. [2005]

3. United States pubmed.ncbi.nlm.nih.gov

The treatment of non-small cell lung cancer: current perspectives and controversies, future directions. [2007]

4. England pubmed.ncbi.nlm.nih.gov

First- and second-line therapy for advanced nonsmall cell lung cancer. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Phase II study of nedaplatin and irinotecan as adjuvant chemotherapy for completely resected non-small cell lung cancer. [2019]