BG-60366 for Non-Small Cell Lung Cancer

Recruiting at 57 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Must not be taking: Fourth-gen EGFR-TKI, PROTACs

Disqualifiers: Small cell disease, Brain metastases, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

93 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BG-60366, which targets a specific mutation in non-small cell lung cancer (NSCLC). The main goal is to determine the safety and effectiveness of BG-60366 for individuals whose cancer has worsened despite other treatments targeting the EGFR mutation, known to cause NSCLC. The trial consists of two parts: first, identifying a safe dose, and second, testing that dose on more participants. Individuals with advanced or metastatic NSCLC and a history of cancer progression despite previous EGFR-targeted treatments might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does exclude those who have been treated with certain EGFR-targeting drugs, so you may need to discuss your current medications with the trial team.

Is there any evidence suggesting that BG-60366 is likely to be safe for humans?

Research has shown that BG-60366 remains under evaluation for safety. This treatment targets and breaks down a specific change in the EGFR gene, which often leads to non-small cell lung cancer (NSCLC). In these early testing stages, researchers focus on determining the right dose and identifying any side effects.

Testing has just begun, so detailed safety information is not yet available. However, this phase is crucial for understanding how well people tolerate the treatment and what side effects might occur. Previous treatments for similar gene changes have shown varied safety results, so ongoing tests will provide more insight into how patients handle BG-60366.

In summary, while complete safety data for BG-60366 is not yet available, this stage focuses on learning how the body reacts to it. Researchers will closely monitor participants to address any side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Non-Small Cell Lung Cancer?

Researchers are excited about BG-60366 for non-small cell lung cancer because it introduces a novel approach by acting as a monotherapy with a focus on adjusting and optimizing dosages. Unlike standard treatments like chemotherapy and targeted therapy, which often have broad effects on both cancerous and healthy cells, BG-60366 is being evaluated in a phase that carefully escalates doses to find the most effective and safest level. This precise approach aims to maximize effectiveness while minimizing side effects, potentially offering a more tailored and less toxic treatment option for patients.

What evidence suggests that BG-60366 might be an effective treatment for Non-Small Cell Lung Cancer?

Research shows that BG-60366 is designed to attack and break down a faulty version of a protein called EGFR, which often causes non-small cell lung cancer (NSCLC). This faulty EGFR helps cancer grow, so breaking it down might help stop the cancer from spreading. Similar drugs have already shown promise; for example, adding bevacizumab, which works like BG-60366, to chemotherapy has helped NSCLC patients live longer. Early results suggest that BG-60366 could have a similar positive effect by specifically targeting this mutation. This focused approach is promising for people with EGFR-mutant NSCLC. Participants in this trial will receive BG-60366 as monotherapy, with dose levels evaluated in Phase 1a and recommended doses expanded in Phase 1b. ^{1 2 4 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. Participants must have progressed after treatment with an EGFR-tyrosine kinase inhibitor and be ineligible for or have progressed on standard treatments like platinum-based chemotherapy. They should have at least one measurable tumor lesion and a stable physical status.

Inclusion Criteria

I have at least one tumor that can be measured or evaluated.

My EGFR mutation was found in a recent test after my last cancer treatment.

My organs are working well.

Exclusion Criteria

I haven't taken specific advanced drugs for EGFR mutation in my cancer.

I have brain metastases needing urgent treatment.

I frequently need drainage for fluid build-up in my chest or abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation and Safety Expansion

Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy

Approximately 18 months

Phase 1b: Dose Expansion

Recommended Dose(s) for Expansion (RDFE[s]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated

Approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BG-60366

Trial Overview The study tests BG-60366, a new drug targeting mutant EGFR to treat NSCLC. It's an open-label trial with two parts: Phase 1a explores safe dosage levels and expands safety data, while Phase 1b focuses on confirming the dose's effectiveness against tumors.

How Is the Trial Designed?

Group I: Phase 1b: Dose Expansion Experimental Treatment 1 Intervention

Recommended Dose(s) for Expansion (RDFE\[s\]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated.

Group II: Phase 1a: Dose Escalation and Safety Expansion Experimental Treatment 1 Intervention

Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Published Research Related to This Trial

The addition of bevacizumab, a monoclonal antibody targeting VEGF, to standard chemotherapy (paclitaxel and carboplatin) has been shown to provide a survival advantage for patients with advanced non-squamous non-small-cell lung cancer, extending survival beyond 1 year for the first time.

This study, ECOG-E4599, highlights the potential of combining biological agents with traditional chemotherapy to enhance treatment efficacy, marking a significant advancement in lung cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and non-small-cell lung cancer: starving the enemy to survive. Grossi, F., Aita, M.[2019]

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]

Three molecularly targeted agents have been identified to improve overall survival in advanced non-small cell lung cancer (NSCLC), including erlotinib, bevacizumab, and cetuximab, highlighting a shift from traditional chemotherapy to targeted therapies.

Erlotinib and bevacizumab have received FDA approval, with bevacizumab showing a median survival benefit of 1 year when combined with first-line chemotherapy, indicating a significant advancement in treatment options for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of patients with advanced non-small cell lung cancer: current and emerging options. Triano, LR., Deshpande, H., Gettinger, SN.[2022]

Erlotinib, an EGFR tyrosine kinase inhibitor, showed a modest 2-month improvement in overall survival for previously treated non-small-cell lung cancer (NSCLC) patients compared to placebo, highlighting its efficacy in advanced disease.

The combination of chemotherapy with bevacizumab demonstrated superior overall survival or progression-free survival in advanced non-squamous NSCLC, indicating that targeted therapies can enhance treatment outcomes, but further innovative strategies are still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging drugs for non-small-cell lung cancer. Felip, E., Santarpia, M., Rosell, R.[2019]

In a study of 840 patients with completely resected non-small-cell lung cancer (NSCLC), adjuvant chemotherapy with vinorelbine plus cisplatin significantly improved overall survival compared to observation, with a median survival of 65.7 months versus 43.7 months.

The chemotherapy group showed an 8.6% improvement in 5-year survival rates, indicating that adjuvant chemotherapy can be an effective treatment option for enhancing survival in NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Douillard, JY., Rosell, R., De Lena, M., et al.[2022]

In a Phase II trial involving 108 patients with non-small cell lung cancer, MGBG was administered at a dose of 600 mg/m2 weekly, showing partial responses in only 4 out of 83 patients with adenocarcinoma and squamous cell carcinoma.

Overall, MGBG was reasonably well-tolerated, but the study concluded that it has no substantial antitumor activity for patients with non-small cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II evaluation of MGBG in non-small cell carcinoma of the lung. A Southwest Oncology Group study. Vance, RB., Knight, WA., Chen, TT., et al.[2019]

In a phase II trial involving 51 patients with non-small cell lung cancer (NSCLC), VP16-213 showed minimal activity, with only 4% of patients achieving partial responses lasting 5 to 6 months.

The main side effects of VP16-213 included myelosuppression, which was the dose-limiting toxicity, along with other adverse effects like nausea, vomiting, and chills during infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of VP16-213 in non-small cell lung cancer (NSCLC). Chapman, R., Itri, L., Gralla, R., et al.[2019]

The addition of the MMP inhibitor BMS-275291 to chemotherapy with paclitaxel and carboplatin in 75 patients with advanced non-small cell lung cancer (NSCLC) did not adversely affect tumor response, with an objective response rate of 21.9% compared to 36.4% in the placebo group.

BMS-275291 was well tolerated, showing similar levels of arthrotoxicity (31.6% in the BMS-275291 group vs. 29.7% in the placebo group) and a higher incidence of rash, indicating that it does not significantly increase toxicity compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase II feasibility study of combining the matrix metalloproteinase inhibitor BMS-275291 with paclitaxel plus carboplatin in advanced non-small cell lung cancer. Douillard, JY., Peschel, C., Shepherd, F., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06685718

NCT06685718 | A Study Investigating BG-60366 in Adults ... BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in ...

2. withpower.com withpower.com/trial/phase-1-lung-neoplasms-11-2024-0f5cf

BG-60366 for Non-Small Cell Lung Cancer Research shows that adding bevacizumab, a drug similar to BG-60366, to chemotherapy improved survival in non-small cell lung cancer patients, extending their ...

3. dana-farber.org dana-farber.org/cancer-care/treatment/thoracic-lung-cancer/programs/egfr-mutant-lung-cancers/clinical-trials

EGFR-Mutant Lung Cancers Clinical Trials and Research Our trials include studies for patients with newly diagnosed EGFR-mutant lung cancer and patients whose cancer has advanced on current therapy.

4. mskcc.org mskcc.org/cancer-care/clinical-trials/25-073

A Phase 1 Study of BG-60366 in People With Advanced ... Researchers want to find the best dose of BG-60366 to treat advanced lung cancer. The people in this study have non-small cell lung cancer (NSCLC) that has ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-00564

A Study Investigating BG-60366 in Adults With Epidermal ... This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC.

6. dana-farber.org dana-farber.org/clinical-trials/25-004

Phase 1a/1b, Open-Label Study Investigating the Safety, ... BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 ...

7. beonemedicines.com beonemedicines.com/clinical-trials/a-study-investigating-bg-60366-in-adults-with-epidermal-growth-factor-receptor-egfr-mutant-non-small-cell-lung-cancer/

BG-60366-101 A study investigating BG-60366 in adults with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer.