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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)

ConditionNon-small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign informed consent and agree to comply with the protocol requirements;

Aged ≥18 years and ≤75 years, regardless of gender;

Expected survival time ≥3 months;

Patients with non-small cell lung cancer;

Disqualifiers

SCLC, mixed SCLC and NSCLC, or other non-NSCLC pathological types;

Trial participants who subsequently receive only segmentectomy or wedge resection;

Trial participants deemed surgically inoperable by the study center's surgical evaluation;

Undergoing major surgery within 4 weeks prior to the first dose, among others;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-B01D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Osimertinib

    Drug

    Oral administration for a cycle of 3 weeks.

  • Carboplatin

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Pemetrexed

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Cisplatin

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: BL-B01D1+OsimertinibExperimental treatment 2 interventions
Group B: OsimertinibActive comparator 1 intervention
Group C: Carboplatin + Pemetrexed or Cisplatin + PemetrexedActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Major Pathological Response (MPR)

MPR is defined as the presence of viable tumor tissue ≤10% in the surgical specimen at the time of tumor resection.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Pathologic complete response (pCR)

pCR is defined as the absence of any residual tumor (lesions) in the primary tumor upon surgical resection.

Time frame
Up to approximately 24 months
2

Event-Free Survival (EFS)

EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first.

Time frame
Up to approximately 24 months
3

Overall Survival (OS)

Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

Time frame
Up to approximately 24 months
4

Treatment Emergent Adverse Event (TEAE)

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: