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

NCT06607796 | Recruiting Phase 3

• 1 other identifier: CROC-24-09
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

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)

  3 years

Secondary Outcomes (2)

• Median progression-free survival(mPFS)

  3 years

• Median overall survival(mOS)

  3 years

Study Arms (2)

Experimental group

EXPERIMENTAL

intratumoral injection of toluenesulfonamide (PTS) to oligo lesions

Drug: Toluenesulfonamide (PTS) Intratumoral Injection

Control subjects

NO INTERVENTION

follow-up observation of oligofocal lesions, no PTS intratumoral injection treatment, if progression can be oligofocal PTS intratumoral injection

Interventions

Toluenesulfonamide (PTS) Intratumoral Injection DRUG

intratumoral injection of toluenesulfonamide(PTS) to oligo lesions

Experimental group

Eligibility Criteria

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

You may qualify if:

• 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；
• Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment；
• ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；
• Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；
• Life expectancy ≥ 3 months；
• Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.

You may not qualify if:

• 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;
• History of severe emphysema and pulmonary alveoli;
• History of drug allergy or contraindication to toluene sulfonamide;
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
• The investigators determined that the patients had other conditions that made them unsuitable for enrollment.

Sponsors & Collaborators

• Zhou Chengzhi: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510145, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

6-pyruvoyltetrahydropterin synthase

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chengzhi Zhou, doctor

  The First Affiliated Hospital of Guangzhou Medical University,Guangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengzhi Zhou, doctor

CONTACT

13560351186; doctorzcz@163.com

Xiaohong Xie, master

CONTACT

13632326736; gyxxh@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

CN (1)