Adjuvant chemotherapy for high-risk early-stage lung adenocarcinoma

Adjuvant Chemotherapy Versus Observation in Fully Resected Stage I Lung Adenocarcinoma With High Risk of Post-operative Recurrence

This study tests whether giving chemotherapy after surgery can help people with high-risk early-stage lung cancer live longer and stay cancer-free compared to just monitoring them.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT03380468 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of adjuvant chemotherapy using cisplatin and pemetrexed compared to observation in patients with high-risk stage I lung adenocarcinoma. The study focuses on patients who have undergone complete surgical resection and are at risk of post-operative recurrence due to specific pathological features. It seeks to determine the impact of chemotherapy on disease-free survival and overall survival while assessing safety and efficacy. The trial also aims to gather data on various clinical and pathological characteristics of the participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with fully resected stage I lung adenocarcinoma exhibiting high-risk features such as solid or micropapillary subtypes, vascular or pleural involvement.

Not a fit: Patients with concurrent malignancies, prior chemotherapy or radiation for lung cancer, or those with central type lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that improves survival rates for patients with high-risk stage I lung adenocarcinoma.

How similar studies have performed: Previous retrospective studies have suggested potential benefits of adjuvant chemotherapy in similar patient populations, but this trial represents a prospective randomized approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Stage pI lung adenocarcinoma confirmed through formalin-fixed paraffin-embedded tumor tissue, complete resection with mediastinal lymph node dissection
2. Meet one of following conditions: a, Solid predominant adenocarcinomas; b, micropapillary predominant adenocarcinoma; c, low differentiation, unable to identify histological subtypes; d, pleural involvement; e, vascular involvement with solid subtype component or micropapillary component.
3. Aged 18-70 years old.
4. Eastern Cooperative Oncology Group score standard (ECOG) status 0-1.
5. Medical condition permits adjuvant chemotherapy.
6. Patients accept the clinical trial protocol and Informed Consent Form (ICF) signed.

Exclusion Criteria:

1. Concurrent other malignancies
2. Prior chemotherapy and/or radiation therapy for lung cancer
3. Central type lung cancer
4. Concurrent other unresected suspicious nodules or masses in lung
5. Medical condition that will not permit treatment or follow up according to the protocol, or ECOG status \>1.
6. Pregnant or nursing women.

Where this trial is running

Shanghai, Shanghai

• Fudan University Cancer Center — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Haiquan Chen, MD — Fudan University
• Study coordinator: Haiquan Chen, MD

Conditions: Lung Neoplasms, Lung adenocarcinoma, adjuvant chemotherapy