TILs Therapy for Multiple Primary Early-Stage NSCLC

Safety Study of Tumor-Infiltrating Lymphocytes (TILs) Therapy for Multifocal Early-Stage Non-Small Cell Lung Cancer (NSCLC)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Early-stage Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: TILs injection

Detailed Description

This study is an open-label, single-arm, prospective clinical trial. 50 subjects with multiple primary early-stage non-small cell lung cancer (NSCLC), including those with malignant pleural effusion, will be enrolled and administered with tumor-infiltrating lymphocytes (TILs) injection therapy. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up, so as to systematically evaluate the safety and effectiveness of TILs treatment for multiple

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years, male or female;
2. 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;
3. 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;
4. Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes;
5. ECOG performance status score of 0-2;
6. HGB ≥70 g/L, transfusion-eligible;

7. 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;

8. Estimated survival > 5 years with complete clinical documentation.

Exclusion Criteria:

1. Patients with pathological diagnosis of small cell lung cancer components;
2. Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;
3. Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;
4. Patients currently undergoing steroid therapy;
5. Concurrent severe or persistent infections unresponsive to effective control;
6. Concurrent severe autoimmune disease or congenital immunodeficiency;
7. History of severe allergic reactions to biological products (including antibiotics);
8. 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);
9. HIV infection or syphilis infection;
10. Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months;
11. Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A single-arm TILs treatment; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
According to the subgroup analysis of TILs in patients with multiple primary early-stage NSCLC to analyze the correlation between TILs and disease prognosis	TILs subgroup analysis Description: Composition, phenotype, and function of TILs	up to three months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
According to the objective response rate (ORR) to evaluate the efficacy of TILs therapy for multiple primary early-stage NSCLC	Objective response rate (ORR) Description：The percentage of subjects with a Complete Response (CR) or Partial Response (PR) determined by RECIST 1.1 criteria.	Up to 12 months

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; TILs
• Other Study ID Numbers: TILs NSCLC-SZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No