Non Small Cell Lung CancerPhase 2NeoTAP01NCT04304248
Neoadjuvant Toripalimab Plus Platinum-based Doublet for Stage III Non-small Cell Lung Cancer
A Phase 2 study testing Albumin-bound paclitaxel, Carboplatin, Toripalimab in people with Non Small Cell Lung Cancer, run by Hao Long at 1 site in China.
Trial summary
This is an open-label, single-arm, phase II, multi-center clinical trial. Thirty patients will be enrolled in this trial to investigate the pathological complete response rate defined as the absence of residual tumor in lung and lymph nodes treated by chemo-immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Albumin-bound paclitaxel, Carboplatin, Toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Jul 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included.
- PET/CT including IV contrast (CT of diagnostic quality) will be performed at baseline (28 days +10 before randomization);
- Tumor should be EGFR wild-type or EML4-ALK negative;
- Tumor should be considered resectable before study entry by a multidisciplinary team;
- ECOG (Performance status) 0-1;
- Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization.
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- Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 x×109/L iii. Hemoglobin > 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or >40% predicted value viii. INR/APTT within normal limits;
- All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention;
- Patients aged > 18 years;
- Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomization.
- All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs;
- Patient capable of proper therapeutic compliance and accessible for correct follow-up;
- Measurable or evaluable disease (according to RECIST 1.1 criteria).
Who cannot join
- All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
- Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
- Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
- Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy
- Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
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- Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
- Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
- Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
- Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Patients with history of allergy to study drug components excipients
- Women who are pregnant or in the period of breastfeeding
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Neoadjuvant Toripalimab Plus Platinum-based Doublet for Potentially Resectable Stage III Non-small Cell Lung Cancer
This is an open-label, single-arm, phase II, multi-center clinical trial. Thirty patients will be enrolled in this trial to investigate the pathological complete response rate defined as the absence of residual tumor in lung and lymph nodes treated by chemo-immunotherapy.
Read the detailed description
This is an open-label, single-arm, phase II, multi-center clinical trial. Eligible patients will receive Toripalimab 240mg + Albumin-bound paclitaxel 260mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days (+/-3 days) as neoadjuvant treatment followed by surgery 3-4 weeks after the last dose of chemo-immunotherapy.
The primary objective is major pathologic response (MPR), defined as less than 10% tumor cells in the pathologically resected specimen. Patient accrual is expected to be completed within 18 months excluding a run-in-phase of 3 months. Patients will be followed 3 years after surgery. The study will end once survival follow-up has concluded.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Albumin-bound paclitaxel, Carboplatin, Toripalimab
- Keywords
- Non small cell lung cancer, neoadjuvant, chemo-immunotherapy, Toripalimab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-bound paclitaxel, Carboplatin, ToripalimabDrug
Eligible patients will receive Toripalimab 240mg + Albumin-bound paclitaxel 260mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days (+/-3 days) as neoadjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemo-immunotherapy | Experimental | Neoadjuvant treatment (Albumin-bound paclitaxel + carboplatin + toripalimab) will start within 1-3 days from enrollment at 21-day (+/-3 days) intervals (Q3W) prior to surgery. Before surgery a tumor assessment will be done to exclude evidence of progression. Patients with radiographically stable disease or partial response may be considered for operation.
Surgery: Surgery must be done within the 3rd to 4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment. Receives: Drug: Albumin-bound paclitaxel, Carboplatin, Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the major pathologic response (MPR)
The major pathologic response is defined as less than 10% tumor cells in the pathologically resected specimen
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
Secondary outcomes (3)
pathologic complete response
defined as no tumor cells observed in pathologically resected specimens
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
Resectable rate
defined as the number of patients who underwent surgical resection/the number of randomized patients in each group
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
Disease-free survival
defined as the interval from the surgery to the observation of confirmed disease recurrence
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Aug 2019
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hao Long
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304248
- Sponsor's protocol ID
- SYSUCC B2019-116-01
- Acronym
- NeoTAP01
- Status last verified
- May 2021
- First submitted
- 9 Mar 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao ZR, Yan WP, Yu XY, Zhang JB, Fang YF, Ma K, Luo QQ, Long H, Chen KN, Jiang L. Adjuvant immunotherapy does not improve survival in non-small cell lung cancer with major/complete pathologic response after induction immunotherapy. J Thorac Cardiovasc Surg. 2025 Jun;169(6):1576-1584.e3. doi: 10.1016/j.jtcvs.2024.11.028. Epub 2024 Nov 29.
PubMed 39617319Zhai W, Zhang C, Duan F, Xie J, Dai S, Lin Y, Yan Q, Rao B, Li L, Zhou Y, Zhao Z, Long H, Wang J. Dynamics of peripheral blood inflammatory index predict tumor pathological response and survival among patients with locally advanced non-small cell lung cancer who underwent neoadjuvant immunochemotherapy: a multi-cohort retrospective study. Front Immunol. 2024 Jul 23;15:1422717. doi: 10.3389/fimmu.2024.1422717. eCollection 2024.
PubMed 39108262Zhao ZR, Yang CP, Chen S, Yu H, Lin YB, Lin YB, Qi H, Jin JT, Lian SS, Wang YZ, You JQ, Zhai WY, Long H. Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer. Oncoimmunology. 2021 Oct 25;10(1):1996000. doi: 10.1080/2162402X.2021.1996000. eCollection 2021.
PubMed 34712513
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Toripalimab Plus Platinum-based Doublet for Potentially Resectable Stage III Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04304248
- Acronym / sponsor ID
- NeoTAP01 / SYSUCC B2019-116-01
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, neoadjuvant, chemo-immunotherapy, Toripalimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hao LongUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 11 Mar 2020 (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.
This is an open-label, single-arm, phase II, multi-center clinical trial. Thirty patients will be enrolled in this trial to investigate the pathological complete response rate defined as the absence of residual tumor in lung and lymph nodes treated by chemo-immunotherapy.
Detailed description
This is an open-label, single-arm, phase II, multi-center clinical trial. Eligible patients will receive Toripalimab 240mg + Albumin-bound paclitaxel 260mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days (+/-3 days) as neoadjuvant treatment followed by surgery 3-4 weeks after the last dose of chemo-immunotherapy.
The primary objective is major pathologic response (MPR), defined as less than 10% tumor cells in the pathologically resected specimen. Patient accrual is expected to be completed within 18 months excluding a run-in-phase of 3 months. Patients will be followed 3 years after surgery. The study will end once survival follow-up has concluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemo-immunotherapy | Experimental | Drug: Albumin-bound paclitaxel, Carboplatin, ToripalimabNeoadjuvant treatment (Albumin-bound paclitaxel + carboplatin + toripalimab) will start within 1-3 days from enrollment at 21-day (+/-3 days) intervals (Q3W) prior to surgery. Before surgery a tumor assessment will be done to exclude evidence of progression. Patients with radiographically stable disease or partial response may be considered for operation. Surgery: Surgery must be done within the 3rd to 4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included.
- PET/CT including IV contrast (CT of diagnostic quality) will be performed at baseline (28 days +10 before randomization);
- Tumor should be EGFR wild-type or EML4-ALK negative;
- Tumor should be considered resectable before study entry by a multidisciplinary team;
- ECOG (Performance status) 0-1;
Key exclusion criteria (13 listed)
- All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
- Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
- Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
- Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy
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 |
|---|---|---|
| Albumin-bound paclitaxel, Carboplatin, ToripalimabEligible patients will receive Toripalimab 240mg + Albumin-bound paclitaxel 260mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days (+/-3 days) as neoadjuvant treatment | Drug | Neoadjuvant chemo-immunotherapy |
Primary outcome
Evaluation of the major pathologic response (MPR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
The major pathologic response is defined as less than 10% tumor cells in the pathologically resected specimen
3 secondary outcomes
pathologic complete response
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
Resectable rate
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
Disease-free survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Derived from this study: PubMed 39617319Zhao ZR, Yan WP, Yu XY, Zhang JB, Fang YF, Ma K, Luo QQ, Long H, Chen KN, Jiang L. Adjuvant immunotherapy does not improve survival in non-small cell lung cancer with major/complete pathologic response after induction immunotherapy. J Thorac Cardiovasc Surg. 2025 Jun;169(6):1576-1584.e3. doi: 10.1016/j.jtcvs.2024.11.028. Epub 2024 Nov 29.
- Derived from this study: PubMed 39108262Zhai W, Zhang C, Duan F, Xie J, Dai S, Lin Y, Yan Q, Rao B, Li L, Zhou Y, Zhao Z, Long H, Wang J. Dynamics of peripheral blood inflammatory index predict tumor pathological response and survival among patients with locally advanced non-small cell lung cancer who underwent neoadjuvant immunochemotherapy: a multi-cohort retrospective study. Front Immunol. 2024 Jul 23;15:1422717. doi: 10.3389/fimmu.2024.1422717. eCollection 2024.
- Derived from this study: PubMed 34712513Zhao ZR, Yang CP, Chen S, Yu H, Lin YB, Lin YB, Qi H, Jin JT, Lian SS, Wang YZ, You JQ, Zhai WY, Long H. Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer. Oncoimmunology. 2021 Oct 25;10(1):1996000. doi: 10.1080/2162402X.2021.1996000. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin-bound paclitaxel, Carboplatin, Toripalimab in people with Non Small Cell Lung Cancer, run by Hao Long 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 13 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 May 2021. 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?
Results are not available in the source record.
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?
Evaluation of the major pathologic response (MPR) (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months). 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 NCT04304248, which also lists 3 linked publications.
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 6 May 2021.