IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.

Eligibility criteria

Qualifiers

The patient shall sign the informed consent.

Age ≥ 18 years.

Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Histologically or cytologically confirmed Stage III (per AJCC 9th) squamous or non-squamous non-small-cell lung cancer (NSCLC) deemed unresectable by the investigator.

Disqualifiers

Non-squamous and squamous NSCLC with EGFR active mutation positive, ALK rearrangement, or any other driver mutation with an approved targeted therapy.

History of other malignant tumors within five years or concurrently present, except adequately treated cervical carcinoma in situ, basal- or squamous-cell skin carcinoma, localized prostate cancer after radical prostatectomy, ductal carcinoma in situ after radical prostatectomy, or other tumor deemed cured by the investigator.

Histologically confirmed the presence of small cell lung cancer component.

Participants who have received any systemic anti-cancer treatment.

Trial design

Treatments tested in this trial

  • IBI363 + Chemotherapy

Treatment groups

43 Participants
are divided into 1 treatment group