The Efficacy and Safety of Sintilimab Plus Chemotherapy in Surgical Conversion for Patients With Unresectable Stage IIIB-IIIC NSCLC: A Prospective, Single-Arm, Phase II Study

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

About this trial

This study aimed to evaluate the conversion rate to curative-intent treatment in patients with unresectable stage IIIB-IIIC non-small cell lung cancer (NSCLC) following induction therapy with PD-1 blockade combined with chemotherapy, and to assess progression-free survival (PFS) in these patients who underwent curative-intent treatment .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patients voluntarily participate in this study and sign informed consent forms (including consent for relevant testing of collected biological samples).

Disqualifiers

1. Patients with NSCLC harboring driver mutations (e.g., EGFR, ALK, ROS1). 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapies targeting T-cell co-stimulatory pathways.

Trial design

Design model

Single group

Treatments tested in this trial

  • chemoimmunothrapy

    Drug

    Patients will receive 3-4 cycles of induction therapy with Sintilimab combined with platinum-based doublet chemotherapy, followed by multidisciplinary team (MDT) evaluation. For patients deemed eligible for radical lung primary lesion resection, surgery should be performed within 4-6 weeks after completing the final cycle of chemoimmunotherapy. The timing of radiotherapy for metastatic lymph nodes will be determined by MDT discussion. If deemed inoperable after induction therapy by MDT, definitive radiotherapy will be administered subsequently. All patients, in the absence of contraindications, will receive PD-1 inhibitor maintenance therapy for 1 year following local treatment.

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: chemoimmunotherapy induction groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

conversion rate

the conversion rate to curative primary lung lesion resetion in patients with unresectable stage IIIB-IIIC NSCLC following induction chemoimmunotherapy

Time frame
up to 20 weeks
2

1-y PFS

the proportion of patients without disease progression in one year after the initial dose of chemoimmumotherapy

Time frame
within one year

Secondary outcomes

1

safety

types and incidence of adverse events occurring during the treatment period

Time frame
up to 2 years
2

the rate of major pathological response (MPR)

the proportion of patients who achieve MRP among those receiving pneumonectomy

Time frame
up to 20 weeks
3

the rate of pathological complete response (pCR)

the proportion of patients who achieve pCR among those receiving pneumonectomy

Time frame
up to 20 weeks
4

PFS

progression-free survival

Time frame
5 years

Other outcomes

1

the survival impact of different treatment modalities for contralateral hilar or mediastinal lymph node metastasis

the survival differences between patients with contralateral hilar or mediastinal lymph node metastasis who received contralateral lymph node radiotherapy versus surgical lymph node dissection

Time frame
within 5 years

Locations

This trial has no locations.

Sponsors and contacts

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