Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)

NCT07120698 | Recruiting Phase 2

• 1 other identifier: 2025-S-174
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.

Conditions

NSCLC (Non-small Cell Lung Cancer); MRD; II-IIIB Stages; Adjuvant Immunotherapy

Keywords

MRD; II-IIIB stages; NSCLC (non-small cell lung cancer); adjuvant immunotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year EFS rate

  Event-free survival (EFS) is defined as the time from the date of randomization (or the start of treatment) to the first occurrence of any of the following events: disease progression, local or distant recurrence, or death due to any cause. If a patient does not experience any of these events within 2 years, they are considered to have achieved 2-year EFS.

  2 year after treatment initiation

Secondary Outcomes (5)

• mEFS

  From enrollment to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)

• 2-year OS rate

  24 months

• mOS

  OS is defined as the time from enrollment to death, regardless of disease recurrence, assessed up to 100 months

• AEs

  24 months

• QoL

  24 months

Other Outcomes (1)

• Analyze the proportion of the four types of pathological response (1%-5% irRVT vs. >5%-30% irRVT vs. >30%-80% irRVT vs. >80% irRVT) and their correlation with median event-free survival (mEFS).

  From enrollment to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)

Study Arms (1)

Experimental arm

EXPERIMENTAL

sintilimab

Drug: Sintilimab

Interventions

Sintilimab DRUG

Patients who met the inclusion criteria were treated with adaptive adjuvant sintilimab therapy guided by MRD. Patients should test twice at postoperative days 3 to 7 and again at postoperative day 28 (±3 days). The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD tests or a single positive MRD test will be enrolled in the MRD+ treatment cycle：they will receive adjuvant treatment with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up visits will be conducted every 3 months, during which chest CT scans and MRD testing will be performed. If MRD becomes negative, treatment will be discontinued and the participant will be monitored. If MRD remains positive, treatment with sintilimab will continue. Participants with two consecutive negative MRD tests will be enrolled in the MRD- treatment cycle：they will undergo follow-up observation only. Follow-up visits will be conducted every 3 months

Experimental arm

Eligibility Criteria

• Age: 28 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to the initiation of any trial-related procedures.
• Male or female aged ≥18 years and ≤75 years.
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
• Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy.
• Underwent radical surgical treatment (R0), with surgical procedures including lobectomy or sleeve lobectomy. All gross tumors must be completely resected at the end of surgery, and all surgical margins of the resected tumors must be negative. Systemic lymph node dissection is required.
• Clinical stage II, IIIA, or IIIB (limited to resectable N2) according to the AJCC 8th edition TNM classification for lung cancer. Resectable N2 refers to non-massive (defined as short-axis diameter \<3 cm), discrete, or single-station N2 involvement. If clinically suspected of N2 or N3, pathological confirmation is recommended whenever feasible.
• Patients with pathological response assessment of 1%-90% residual viable tumor (RVT).
• No EGFR mutations, ROS1 fusions, ALK fusions, or RET fusions. Other potentially targetable driver gene alterations will be determined in consultation with the sponsor.
• No prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy before radical surgery for lung cancer.
• Completed radical surgery for lung cancer 4-12 weeks prior to study enrollment, with pathological confirmation of R0 resection and radiological evidence of no residual tumor foci 1 month after radical surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy \>6 months.
• Adequate organ function:
• \. Absolute neutrophil count (ANC) ≥1.5×10\^9/L without the use of granulocyte colony-stimulating factor within the past 14 days.
• \. Platelets ≥100×10\^9/L without transfusion within the past 14 days. 3. Hemoglobin \>9 g/dL without transfusion or use of erythropoiesis-stimulating agents within the past 14 days.

You may not qualify if:

• Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected).
• Received adjuvant radiotherapy prior to dosing.
• Patients who underwent pneumonectomy.
• Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
• Received neoadjuvant treatment with anti-tumor therapies other than chemotherapy and immunotherapy.
• Presence of unhealed surgical incisions, ulcers, or fractures.
• In the investigator's opinion, severe concomitant systemic diseases that may affect the subject's ability to complete the study. Subjects with positive autoimmune antibodies must be assessed and confirmed by the investigator to have no autoimmune diseases requiring systemic treatment before enrollment.
• Presence of primary immunodeficiency diseases.
• Receiving systemic corticosteroid therapy within 7 days prior to the first dose of the study (excluding intranasal, inhaled, or other topical corticosteroids). Note: The use of physiologic doses of corticosteroids (≤10 mg/day prednisone or equivalent) is permitted.
• Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• Known allergy to the active ingredient or excipients of the study drug, sintilimab.
• Not fully recovered from toxicities and/or complications caused by any prior interventions prior to the start of treatment (i.e., ≤Grade 1 or returned to baseline, excluding fatigue or alopecia).

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead
• Zunyi Medical College: collaborator
• Suining Central Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator

Study Sites (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

The third people's hospital of chengdu

Chengdu, Sichuan, 610031, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yang

  Guangdong Association of Clinical Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Yang

CONTACT

+8613980013944; cd3yyyy@126.com

Benyuan Jiang

CONTACT

15918748727; jiangbenyuan@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: Model Description

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 13, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): June 26, 2029
• Study Completion (Estimated): July 26, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)