TILs Therapy for Multiple Primary Early-Stage NSCLC

ConditionPrimary Early-stage Non-small Cell Lung Cancer

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorTianjin Medical University General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: A single-arm TILs treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

up to three years

Secondary outcomes

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

Time frame

up to three months

Other outcomes

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.

Time frame

Up to 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University General Hospital

Lead sponsor

Source ClinicalTrials.gov

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