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Recruiting
NCT07642024
A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)
Conditions: Non-small Cell Lung Cancer
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 90
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Location: Shanghai East Hospital Shanghai Shanghai Municipality
Summary
This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria:
1. Voluntarily sign informed consent and agree to comply with the protocol requirements;
2. Aged ≥18 years and ≤75 years, regardless of gender;
3. Expected survival time ≥3 months;
4. Patients with non-small cell lung cancer;
5. One of the EGFR sensitive mutation types detected in the tumor tissue;
6. Agree to provide archived primary tumor tissue specimens obtained within 12 months or fresh tissue samples;
7. Undergo pulmonary function testing within 28 days prior to the first dose;
8. ECOG performance status score of 0 or 1;
9. No severe cardiac dysfunction;
10. Organ function levels must meet the required criteria;
11. Urine protein ≤1+ or \
Source: ClinicalTrials.gov (NCT07642024). StuddyBuddy aggregates publicly available trial information.
