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Advanced Non Small Cell Lung CancerPhase 2TOGATHERNCT04144608

Toripalimab Combined With Double Platinum-based Chemotherapy for Initially Unresectable NSCLC

A Phase 2 study testing Toripalimab in people with Advanced Non Small Cell Lung Cancer, run by Yongchang Zhang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study was to investigate the efficacy of Toripalimab Combined with Double Platinum Based Chemotherapy for Initially Unresectable Non-driver Gene Mutation Non-small Cell Lung Cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Non Small Cell Lung Cancer
What is being tested?
Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
16 Jan 2020to 30 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who have fully understood the trial and are willing to sign the informed consent form.
  • Ages between 18 years old to 70 years old, with no gender restrictions.
  • Previously untreated, histologically confirmed, potentially resectable stage IIIA-IIIB NSCLC (AJCC staging 8th edition); potentially resectable refers to patients with T3 or T4 primary lesions and positive N1 or N2 lymph nodes who are expected to be difficult to resect or require pneumonectomy after discussion by MDT (including surgery, imaging, anesthesia, and internal medicine).
  • Patients diagnosed with squamous cell carcinoma do not need genetic testing. If the test is positive for EGFR, ALK or ROS1, it is considered an exclusion criterion; if it is adenocarcinoma, genetic testing must include at least EGFR, ALK, and ROS1. The acceptable detection methods are ARMS or NGS, where NGS is a cFDA-approved test kit.
  • Measurable lesions according to Response Evaluation Criteria in Solid Tumors Version 1.1.
  • Before enrollment, 20 tissue sections (thickness 4-6 microns) must be submitted for biomarker evaluation (tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment; fresh tissue must be core needle biopsy, excision, or incision biopsy specimens).
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  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
  • Good organ function:
  • Hematology: absolute neutrophil count (ANC) ≥ 1500/μL; platelets ≥ 100,000/μL; hemoglobin ≥ 9.0g/dL or ≥ 5.6 mmol/L;
  • Kidney: serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cock-Gault formula);
  • Liver: Total bilirubin ≤ 1.5 × ULN or direct bilirubin within normal limits for subjects with total bilirubin levels > 1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN;
  • Endocrine system: Thyroid stimulating hormone (TSH) within normal limits. Note: If TSH is not within the normal range at baseline, the subject may still meet the inclusion criteria if T3 and free T4 are within the normal range;
  • Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except for subjects who are receiving anticoagulant therapy, as long as PT or aPTT is within the intended use range of the anticoagulant drug; (1)Cardiac function test: Baseline electrocardiogram shows no PR interval prolongation or atrioventricular block;
  • Total lung function is adequate to sustain the planned lung resection, as assessed by the surgeon.
  • Women must agree to use contraceptive measures (such as intrauterine devices (IUDs), birth control pills or condoms) during the study and within 6 months after the study ends; serum or urine pregnancy tests must be negative within 7 days before study enrollment, and must not be breastfeeding patients; men must agree to use contraceptive measures during the study and within 6 months after the study ends.

Who cannot join

  • Histopathological identification is neuroendocrine carcinoma or sarcomatoid tumor.
  • Resectable disease in the early stage.
  • Subjects with known EGFR mutations or ALK, ROS1 translocations, and subjects with non-squamous cell carcinoma need to clarify the EGFR, ALK and ROS1 mutation status.
  • Early-stage NSCLC who have received prior systemic anticancer therapy, including investigational drugs.
  • History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids, or current pneumonitis/interstitial lung disease requiring steroids.
  • Known history of active tuberculosis.
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  • Known active infection requiring systemic therapy.
  • Subjects with any known or suspected autoimmune disease or immunodeficiency, except patients with a history of hypothyroidism who do not require hormone therapy or are receiving physiological doses of hormone replacement therapy; subjects with stable type 1 diabetes with controlled blood glucose.
  • Subjects with active hepatitis B (defined as a positive result of hepatitis B virus surface antigen [HBsAg] test during the screening period and a HBV-DNA test value higher than the upper limit of the normal value of the laboratory department of the research center) or hepatitis C (defined as a positive result of hepatitis C virus surface antibody [HCsAb] test during the screening period and a positive HCV-RNA test result).
  • Known human immunodeficiency virus (HIV) infection (known HIV antibody positive).
  • Live vaccines within 30 days prior to first dose. Including but not limited to the following: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines (inactivated virus vaccines are permitted).
  • Have grade ≥ 2 peripheral neuropathy.
  • Patients who have received previous treatment with PD-1/PD-L1 drugs or another drug targeting T cell receptors (e.g. CTLA-4, OX-40, etc.).
  • Patients with any severe and/or uncontrolled illness:
  • (1)patients with unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; patients with poorly controlled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);.
  • (2)active or uncontrolled severe infection; (3)liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4)poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); (5)patients with urine routine test indicating urine protein ≥ ++ and confirmed 24-hour urine protein quantitative > 1.0g; (6)patients with a history of psychotropic drug abuse and unable to quit or with mental disorders; (7)Use of immunosuppressive drugs within 2 weeks before the first study drug treatment, excluding topical glucocorticoids or systemic glucocorticoids not exceeding 10 mg/day of prednisone or other glucocorticoids at equivalent doses.
  • 15.Pregnant or lactating women. 16.Prisoners who are illegally imprisoned or detained for reasons other than mental illness or physical illness (such as infectious diseases).
  • 17.Patients with bleeding tendencies (eg., active peptic ulcers) or who are treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogs.
  • 18.History of study drug allergy. 19.According to the researcher's judgment, patients with concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hunan Provincal Tumor Hospital

    Changsha, Hunan, 410013

Other trials in China

About this study

Official title: A Phase II Study on Toripalimab Combined With Double Platinum Based Chemotherapy for as a Neoadjuvant Therapy for Initially Unresectable Non-driver Gene Mutation Non-small Cell Lung Cancer

The aim of the study was to investigate the efficacy of Toripalimab Combined with Double Platinum Based Chemotherapy for Initially Unresectable Non-driver Gene Mutation Non-small Cell Lung Cancer.

Read the detailed description

The aim of the study was to investigate the efficacy of Toripalimab Combined with Double Platinum Based Chemotherapy for Initially Unresectable Non-driver Gene Mutation Non-small Cell Lung Cancer. Other multiple Omics data will be analyzed to predict the MPR for treatment outcomes.

Being tested
Toripalimab
Keywords
Toripalimab NSCLC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    Also called platinum-based chemotherapy

    Nab-paclitaxel/pem +cisplatin +PD-1(Nab-paclitaxel260mg/m2 D1 Cisplatin 75mg/m2 D1 or carboplatin,determined by the investigator AUC)PD-1 200mg D1

Study groups in NCT04144608
Study groupRoleWhat they receive
Toripalimab Combined With Platinum-containing Dual-agentExperimentalToripalimab combined with platinum-containing dual-agent as a neoadjuvant Therapy for Non-small Cell Lung Cancer
Receives: Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 surgical resection rate

    No residual ratio under the microscope after surgical resection

    Measured: Approximately 1 years

Secondary outcomes (6)

  1. ORR

    To measure the patients's overall response rate

    Measured: Approximately 2 years

  2. Major Pathological Response (MPR) rate

    defined as noadjuvant therapy-induced tumor regression in pathologically residual tumor cells <10%

    Measured: Approximately 2 years

  3. Complete Response (pCR) rate

    Defined as non-adjuvant therapy-induced tumor regression in absence of pathologically residual tumor cells

    Measured: Approximately 2 years

  4. Event-Free Survival (EFS)

    Defined as the time from the first dose treatment to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.

    Measured: Approximately 2 years

  5. Disease-Free Survival (DFS)

    Defined as the time from surgery to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.

    Measured: Approximately 2 years

  6. Overall Survival (OS)

    Defined as the time from the first dose treatment to death.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start16 Jan 2020
  3. Primary completion30 Jun 2022
  4. Study completion30 Jul 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04144608
Sponsor's protocol ID
TOGATHER
Acronym
TOGATHER
Status last verified
Aug 2024
First submitted
28 Oct 2019
Last updated
9 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zeng L, Yan H, Jiang W, Qin H, Dai J, Zhang Y, Wei S, Chen S, Liu L, Xiong Y, Yang H, Li Y, Wang Z, Deng L, Xu Q, Peng L, Zhang R, Fang C, Chen X, Deng J, Wang J, Li T, Liu H, Zhang G, Yang N, Zhang Y. Toripalimab plus platinum-doublet chemotherapy as perioperative therapy for initially unresectable NSCLC: An open-label, phase 2 trial. Med. 2025 Jun 13;6(6):100574. doi: 10.1016/j.medj.2025.100574. Epub 2025 Jan 31.

    PubMed 39892382

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with Advanced Non Small Cell Lung Cancer, run by Yongchang Zhang 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 15 inclusion and 19 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: finished, as of the sponsor's last update on 9 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 surgical resection rate (time frame: Approximately 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04144608, which also lists 1 linked publication.

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 9 Aug 2024.

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