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Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy

ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhou Chengzhi

About this trial

The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures；

Age ≥18 years and ≤75 years at the time of signing the ICF；

Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；

At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection；

Disqualifiers

Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;

Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;

Have severe bleeding, clotting disorders, infections, dehydration, etc;

Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toluenesulfonamide (PTS) Intratumoral Injection

    Drug

    intratumoral injection of toluenesulfonamide(PTS) to oligo lesions

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control subjectsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

Proportion of target lesions stabilized after two courses of first-line chemoimmunotherapy standard therapy combined with and without PTS intratumoral injection, with tumor volume reduction to achieve complete remission (CR) and partial remission (PR)

Time frame
3 years

Secondary outcomes

1

Median progression-free survival(mPFS)

Time from receipt of first-line chemoattenuated standard of care in combination with or without PTS intratumoral injection until first objectively documented disease progression or death from any cause (whichever occurs first)

Time frame
3 years
2

Median overall survival(mOS)

Time from receipt of first-line chemoattenuated standard of care in combination with or without PTS intratumoral injection until death from any cause (whichever occurs first)

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Zhou Chengzhi

Lead sponsor

Guangzhou Institute of Respiratory Disease

Sponsor institution

Source ClinicalTrials.gov
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