TILs Therapy for Multiple Primary Early-Stage NSCLC

NCT07498439 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: TILs NSCLC-SZ
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC

Conditions

Primary Early-stage Non-small Cell Lung Cancer

Keywords

TILs; NSCLC

Outcome Measures

Primary Outcomes (1)

• According to the incidence of treatment-related adverse events（AEs）to evaluate the safety of Tumor-Infiltrating Lymphocytes (TILs) therapy for multiple primary early-stage Non-Small Cell Lung Cancer （NSCLC）

  Incidence of treatment-related adverse events（AEs）Description: Number and severity of adverse events graded according to CTCAE v5.0.

  up to three years

Secondary Outcomes (1)

• According to the subgroup analysis of TILs in patients with multiple primary early-stage NSCLC to analyze the correlation between TILs and disease prognosis

  up to three months

Other Outcomes (1)

• According to the objective response rate (ORR) to evaluate the efficacy of TILs therapy for multiple primary early-stage NSCLC

  Up to 12 months

Study Arms (1)

A single-arm TILs treatment

EXPERIMENTAL

Experimental: Surgically collect fresh tumor tissue or malignant pleural effusion to isolate immune cells, and prepare TILs Infusion. Trial product: TILs Injection. Administration route: Intravenous Infusion

Drug: TILs injection

Interventions

TILs injection DRUG

Experimental: Surgically collect fresh tumor tissue or malignant pleural effusion to isolate immune cells, and prepare TILs Infusion. Trial product: TILs Injection. Administration route: Intravenous Infusion

A single-arm TILs treatment

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years, male or female;
• Imaging findings showing multiple pulmonary nodules persisting after one year of follow-up, clinically diagnosed as multiple lung cancers by two associate senior or higher-level radiologists, two associate senior or higher-level thoracic surgeons, and one associate senior or higher-level oncologist, with patients refusing continued observation;
• Patients with a history of surgical resection and pathological diagnosis of NSCLC, who subsequently show disease progression on imaging (progression of primary lesion or new nodules) during follow-up or after targeted therapy, diagnosed as lung cancer by a multidisciplinary expert team, and who refuse surgery or other treatments;
• Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes;
• ECOG performance status score of 0-2;
• HGB ≥70 g/L, transfusion-eligible;
• No severe hepatic, renal, cardiac, or pulmonary dysfunction, meeting the following criteria:
• Creatinine ≤ 1.5 × ULN; Oxygen saturation \> 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;
• Estimated survival \> 5 years with complete clinical documentation.

You may not qualify if:

• Patients with pathological diagnosis of small cell lung cancer components;
• Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;
• Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;
• Patients currently undergoing steroid therapy;
• Concurrent severe or persistent infections unresponsive to effective control;
• Concurrent severe autoimmune disease or congenital immunodeficiency;
• History of severe allergic reactions to biological products (including antibiotics);
• Active hepatitis (quantitative hepatitis B virus DNA \[HBV-DNA\] above the lower limit of detection for the assay method, or positive hepatitis C antibodies \[HCV-Ab\] with HCV-RNA above the assay method's lower limit of detection);
• HIV infection or syphilis infection;
• Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months;
• Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share