Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Not yet enrolling; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Sintilimab; Drug: LM-108+Sintilimab; Drug: IBI310+Sintilimab; Drug: IBI363

Study type: Interventional

Funder types: Other

Identifiers

NCT06620822

STAR011

Details and patient eligibility

About

Exploring the efficacy of PD-1 inhibitor combination therapy strategies for adjuvant therapy in a population that has not achieved major pathological regression after neoadjuvant immunotherapy for non-small cell lung cancer: a multicenter, phase II clinical study

Full description

This study explores the potential resistance problem in patients with low response rates after neoadjuvant ICIs treatment by addressing their potential resistance problems through an adjuvant immune combination regimen of ICIs, with the aim of providing a personalized choice of perioperative regimens for patients with early stage II-III resectable NSCLC, and to reduce the risk of postoperative recurrence and death in patients.

Enrollment: 296 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects ≥ 18 years of age on the day of signed informed consent, male or female, and willing to follow study procedures;
2. ECOG score of 0 ~ 1;
3. Patients with resectable clinical stage II-IIIB (N2 only) NSCLC prior to neoadjuvant as assessed by the investigator (AJCC 8th ed.) and who are receiving 3 to 4 courses of standard PD-1 monoclonal antibody in combination with chemotherapy (platinum-containing two-agent chemotherapy) as neoadjuvant therapy during the neoadjuvant phase
4. Pathological evaluation of tumor for MPR (less than 10% residual tumor cells from the primary tumor) and specific remission rate (1 - residual tumor/primary tumor)
5. Subjects must have had complete resection of the NSCLC (no residual tumor and all surgical margins negative)
6. Histologically or cytologically confirmed squamous or non-squamous NSCLC.

Exclusion criteria

1. Subjects who have undergone segmental lung resection or wedge resection only, and subjects who have not undergone systemic or lobe-specific lymph node dissection;
2. Postoperative treatment with off-protocol antitumor therapy (e.g., radiotherapy, chemotherapy, targeted therapy, other immunotherapies, etc.; antitumor herbal therapies require a 2-week washout period);
3. Severe grade 3 or higher irAE or severe organ damage during neoadjuvant immunotherapy;
4. Previous history of allogeneic bone marrow or organ transplantation;
5. Previous or current interstitial pneumonitis/lung disease requiring systemic hormone therapy;
6. Uncontrolled hypertension (blood pressure ≥150/90 mmHg at rest), with antihypertensive medications maintained at a stable dose for 7 days prior to the first dose of study drug;
7. Combination of other malignant tumors within 5 years prior to the first dose of study drug that require active treatment, except for tumors cured in the opinion of the investigator;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 4 patient groups

Sintilimab

Active Comparator group

Treatment:

Drug: Sintilimab

LM-108+Sintilimab

Experimental group

Treatment:

Drug: LM-108+Sintilimab

IBI310+Sintilimab

Experimental group

Treatment:

Drug: IBI310+Sintilimab

IBI363

Experimental group

Treatment:

Drug: IBI363