Non Squamous Non Small Cell Lung CancerPhase 2NCT05962021
Neoadjuvant Toripalimab for Non-squamous NSCLC With EGFR Mutation
A Phase 2 study testing Toripalimab plus Chemotherapy in people with Non Squamous Non Small Cell Lung Cancer and EGFR Positive Non-small Cell Lung Cancer, run by Peking University People's Hospital.
Trial summary
This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the… Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Non Squamous Non Small Cell Lung Cancer, EGFR Positive Non-small Cell Lung Cancer
- What is being tested?
- Toripalimab plus Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jun 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of signed informed consent by the patient or legally acceptable representative;
- Previously untreated, histologically confirmed resectable stage II-IIIA, IIIB(N2) (AJCC staging 8th edition) non-squamous non-small cell lung cancer;
- Adequate tissue samples for PD-L1 immunohistochemical testing and gene mutations test by RT-pCR or NGS, or consent for blood RT-PCR or NGS if tissue samples are insufficient;
- Harboring EGFR mutation (19del or L858R);
- Aged 18-70 years, regardless of gender;
- Eastern Cooperative Group (ECOG) Performance Status 0-1;
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- Acceptable cardiac function with a left ventricular ejection fraction >50%;
- Acceptable respiratory function (FEV1>1.5L, DLCO>50%) and ability to tolerate radical lung cancer surgery;
- Acceptable bone marrow haematopoiesis with leucocytes ≥ 4 x 10^9/L, neutrophils ≥ 1.5 x 10^9/L, haemoglobin ≥ 10g/dL and platelets ≥ 100 x 10^9/L;
- Acceptable renal function with a glomerular filtration rate ≥ 60 mL/min;
- Acceptable liver function with total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, and ALT ≤ 3 x ULN;
- Presence of measurable lesions as defined by RECIST 1.1 criteria;
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 3 days prior to the start of study treatment, and agree to use effective contraception for the duration of study drug use and for 120 days after the last dose. Women of childbearing potential were defined as sexually mature females who 1) had not undergone hysterectomy or bilateral oophorectomy and 2) had not experienced spontaneous menopause for 12 consecutive months (amenorrhea after cancer treatment did not preclude fertility) (menstruation had occurred at any time during the previous 12 consecutive months).
Who cannot join
- Pathological histologically confirmed small cell lung cancer, squamous epithelial cell carcinoma and other pathological subtypes cannot be enrolled;
- Patients with advanced or metastatic lung cancer, or unresectable lung cancer, or who have received previous systemic anti-tumour therapy such as immunotherapy, chemotherapy or targeted therapy cannot be enrolled;
- Patients with a history of active autoimmune disease or autoimmune disease that is likely to recur cannot be enrolled;
- Patients with active hepatitis B and C requiring relevant antiviral therapy need to have HBV-DNA <500 IU/ml and have been on anti-HBV treatment for at least 14 days prior to study entry and continue treatment during the treatment period; HCV RNA-positive patients should be excluded;
- Patients who are allergic to chemotherapeutic agents such as carboplatin, paclitaxel, albumin paclitaxel, pemetrexed;
- Patients with a history of allergy to monoclonal antibody drugs;
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- Patients who have previously received an allogeneic stem cell transplant or organ transplant；
- Patients with mental illness or any other illness that makes it impossible to comply with treatment；
- Patients who are unable or unwilling to sign the informed consent form；
- Patients with comorbidities or other conditions that, in the opinion of the investigator, may affect compliance with the protocol or make them unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neoadjuvant Toripalimab Plus Chemotherapy for Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation: a Multicentre, Multi-cohort, Exploratory Study.
This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.
Read the detailed description
Previous studies have confirmed the efficacy of neoadjuvant immunotherapy in NSCLC patients without driver gene mutation, while its efficacy in driver gene mutated patients is still controversial. This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.
- Being tested
- Toripalimab plus Chemotherapy
- Keywords
- Non squamous non small cell lung cancer, EGFR Mutation, Neoadjuvant immuno-chemotherapy, Predictive and prognostic biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab plus ChemotherapyDrug
Therapy was administered on a 21-day regimen for 3 cycles, with Toripalimab (240mg, d1), carboplatin (AUC=5, d1) + pemetrexed (500 mg/m2, d1) for patients with lung adenocarcinoma and carboplatin (AUC=5, d1) + albumin-bound paclitaxel (260 mg/m2, d1) for patients with other subtypes.
| Study group | Role | What they receive |
|---|---|---|
| 19DEL cohort | Experimental | Patients who participated in the trial with EGFR 19DEL mutation will be included in this arm. Receives: Drug: Toripalimab plus Chemotherapy |
| L858R cohort | Experimental | Patients who participated in the trial with EGFR L858R mutation will be included in this arm Receives: Drug: Toripalimab plus Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by blinded independent pathological review (BIPR).
Measured: Within 1 week after surgery
Secondary outcomes (7)
Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) rate is defined as the percentage of participants with less than or equal to 10% of residual viable tumor in lung primary or lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
Measured: Within 1 week after surgery
Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different EGFR mutations status
Assessing pCR rates in the 19del and L858R groups separately.
Measured: Within 1 week after surgery
Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different EGFR mutations status
Assessing MRP rates in the 19del and L858R groups separately.
Measured: Within 1 week after surgery
Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different PD-L1 expression levels
Assessing pCR rates in the PD-L1 TPS≥1% and PD-L1 TPS<1% groups separately.
Measured: Within 1 week after surgery
Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different PD-L1 expression levels
Assessing MRP rates in the PD-L1 TPS≥1% and PD-L1 TPS<1% groups separately.
Measured: Within 1 week after surgery
Event-free Survival (EFS)
EFS is defined as the time from participation to any of the following events: progression of disease, recurrence disease, or death due to any cause. Progression/recurrence will be assessed either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 24 months after participation
The Safety and Tolerability
To assess the safety and tolerability of neoadjuvant immuno-chemotherapy in patients with resectable stage II-IIIB non-squamous non-small cell lung cancer harboring EGFR mutations, including as follows: number, frequency and proportion of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) and on-study deaths.
Measured: Up to 24 months after participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Squamous 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients were divided into the 19del and L858R groups according to their EGFR mutation status.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Principal investigator, Yang Fan, MD, Peking University People's Hospital
- Investigators
- Fan Yanf, M.D., Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962021
- Sponsor's protocol ID
- JS001-ISS-CO413
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Toripalimab Plus Chemotherapy for Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation: a Multicentre, Multi-cohort, Exploratory Study.
- ClinicalTrials.gov ID
- NCT05962021
- Acronym / sponsor ID
- JS001-ISS-CO413
- Keywords
- Non squamous non small cell lung cancer, EGFR Mutation, Neoadjuvant immuno-chemotherapy, Predictive and prognostic biomarker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Jul 2023 (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 study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.
Detailed description
Previous studies have confirmed the efficacy of neoadjuvant immunotherapy in NSCLC patients without driver gene mutation, while its efficacy in driver gene mutated patients is still controversial. This study was designed to investigate the efficacy and safety of neoadjuvant Toripalimab (anti-PD1) plus chemotherapy for patients with resectable II-IIIB non-squamous NSCLC harboring EGFR mutation, and to explore the potential predictive and prognostic biomarkers, aiming to provide more abundant evidences for the preoperative treatment decision of non-squamous NSCLC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were divided into the 19del and L858R groups according to their EGFR mutation status.
| Arm | Type | Receives |
|---|---|---|
| 19DEL cohort | Experimental | Drug: Toripalimab plus ChemotherapyPatients who participated in the trial with EGFR 19DEL mutation will be included in this arm. |
| L858R cohort | Experimental | Drug: Toripalimab plus ChemotherapyPatients who participated in the trial with EGFR L858R mutation will be included in this arm |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Provision of signed informed consent by the patient or legally acceptable representative;
- Previously untreated, histologically confirmed resectable stage II-IIIA, IIIB(N2) (AJCC staging 8th edition) non-squamous non-small cell lung cancer;
- Adequate tissue samples for PD-L1 immunohistochemical testing and gene mutations test by RT-pCR or NGS, or consent for blood RT-PCR or NGS if tissue samples are insufficient;
- Harboring EGFR mutation (19del or L858R);
- Aged 18-70 years, regardless of gender;
Key exclusion criteria (10 listed)
- Pathological histologically confirmed small cell lung cancer, squamous epithelial cell carcinoma and other pathological subtypes cannot be enrolled;
- Patients with advanced or metastatic lung cancer, or unresectable lung cancer, or who have received previous systemic anti-tumour therapy such as immunotherapy, chemotherapy or targeted therapy cannot be enrolled;
- Patients with a history of active autoimmune disease or autoimmune disease that is likely to recur cannot be enrolled;
- Patients with active hepatitis B and C requiring relevant antiviral therapy need to have HBV-DNA <500 IU/ml and have been on anti-HBV treatment for at least 14 days prior to study entry and continue treatment during the treatment period; HCV RNA-positive patients should be excluded;
- Patients who are allergic to chemotherapeutic agents such as carboplatin, paclitaxel, albumin paclitaxel, pemetrexed;
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 |
|---|---|---|
| Toripalimab plus ChemotherapyTherapy was administered on a 21-day regimen for 3 cycles, with Toripalimab (240mg, d1), carboplatin (AUC=5, d1) + pemetrexed (500 mg/m2, d1) for patients with lung adenocarcinoma and carboplatin (AUC=5, d1) + albumin-bound paclitaxel (260 mg/m2, d1) for patients with other subtypes. | Drug | 19DEL cohort, L858R cohort |
Primary outcome
Pathologic Complete Response (pCR) Rate
Time frame: Within 1 week after surgery
Pathologic complete response (pCR) rate is defined as the percentage of participants with no residual viable tumor in lung primary or lymph nodes as evaluated by blinded independent pathological review (BIPR).
7 secondary outcomes
Major Pathologic Response (MPR) Rate
Time frame: Within 1 week after surgery
Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different EGFR mutations status
Time frame: Within 1 week after surgery
Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different EGFR mutations status
Time frame: Within 1 week after surgery
Pathologic Complete Response (pCR) Rate in non-squamous NSCLC with different PD-L1 expression levels
Time frame: Within 1 week after surgery
Major Pathologic Response (MPR) Rate in non-squamous NSCLC with different PD-L1 expression levels
Time frame: Within 1 week after surgery
Event-free Survival (EFS)
Time frame: Up to 24 months after participation
The Safety and Tolerability
Time frame: Up to 24 months after participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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.
Fan Yanf, M.D. study chair
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab plus Chemotherapy in people with Non Squamous Non Small Cell Lung Cancer and EGFR Positive Non-small Cell Lung Cancer, run by Peking University People's Hospital.
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 10 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Fan Yang, M.D. (+86-010-88326657, yangfan@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) Rate (time frame: Within 1 week after surgery). 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 1 Aug 2023.