Lung CancerPhase 3NCT06607796
Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy
A Phase 3 study testing Toluenesulfonamide (PTS) Intratumoral Injection in people with Lung Cancer, run by Zhou Chengzhi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Toluenesulfonamide (PTS) Intratumoral Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510145
Chengzhi Zhou, doctor, 13560351186, doctorzcz@163.com
Xiaohong Xie, master, 13632326736, gyxxh@126.com
About this study
Official title: A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer
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
- Being tested
- Toluenesulfonamide (PTS) Intratumoral Injection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toluenesulfonamide (PTS) Intratumoral InjectionDrug
intratumoral injection of toluenesulfonamide(PTS) to oligo lesions
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | intratumoral injection of toluenesulfonamide (PTS) to oligo lesions Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Secondary outcomes (2)
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)
Measured: 3 years
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, doctor, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University,Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607796
- Sponsor's protocol ID
- CROC-24-09
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06607796
- Acronym / sponsor ID
- CROC-24-09
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Toluenesulfonamide (PTS) Intratumoral Injectionintratumoral injection of toluenesulfonamide (PTS) to oligo lesions |
| Control subjects | No intervention | –follow-up observation of oligofocal lesions, no PTS intratumoral injection treatment, if progression can be oligofocal PTS intratumoral injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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；
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toluenesulfonamide (PTS) Intratumoral Injectionintratumoral injection of toluenesulfonamide(PTS) to oligo lesions | Drug | Experimental group |
Primary outcome
Objective response rate(ORR)
Time frame: 3 years
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)
2 secondary outcomes
Median progression-free survival(mPFS)
Time frame: 3 years
Median overall survival(mOS)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chengzhi Zhou, doctor principal investigator
The First Affiliated Hospital of Guangzhou Medical University,Guangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toluenesulfonamide (PTS) Intratumoral Injection in people with Lung Cancer, run by Zhou Chengzhi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengzhi Zhou, doctor (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.