Lung CancerPhase 2Peri-ENCT06688656
Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant NSCLC
A Phase 2 study testing Pemetrexed 500 mg/m2, carboplatin and Sintilimab in people with Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This study is a prospective, single-arm, single-center Phase II trial, aiming to investigate efficacy and safety of neoadjuvant chemotherapy sequentially combined with sintilimab in resectable EGFR-mutant stage II-IIIB non-squamous NSCLC patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Pemetrexed 500 mg/m2, carboplatin and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Mar 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent prior to any study-related procedures;
- Be aged ≥18 years;
- Have a histopathologically confirmed diagnosis of stage II-IIIB (N2) non-squamous NSCLC, as per the9th edition TNM staging system by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer, with suspected N2 disease confirmed via mediastinoscopy or EBUS;
- Have histologically, cytologically, or hematologically confirmed presence of EGFR-sensitive mutations (Ex19del, L858R), with co-existing driver mutations allowed;
- Have sufficient tissue samples for PD-L1 immunohistochemistry and NGS mutation testing; if tissue samples are inadequate, consent to undergo blood NGS testing;
- PD-L1 expression level ≥1%;
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- Have at least one radiologically measurable lesion as per the RECIST criteria version1.1;
- Be assessed by a surgeon as having pulmonary or other organ function sufficient to tolerate local surgical treatment;
- Have no prior history of anti-tumor treatment;
- Have an ECOG performance status of0-1;
- Have an expected survival time >3 months;
- Possess adequate organ function, meeting the following laboratory criteria: a) Absolute neutrophil count (ANC) ≥1.5x10^9/L without the use of granulocyte colony-stimulating factor within the past14 days; b) Platelets ≥100x10^9/L without transfusion within the past14 days; c) Hemoglobin >9g/dL without transfusion or use of erythropoiesis-stimulating agents within the past14 days; d) Total bilirubin ≤1.5 times the upper limit of normal (ULN); e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN (ALT or AST ≤5 times ULN allowed in subjects with liver metastases); f) Creatinine ≤1.5 times ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; g) Adequate coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; h) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. Subjects with baseline TSH outside the normal range may be included if total T3 (or FT3) and FT4 are within normal limits; i) Cardiac enzymes within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator may also be included);
- For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within3 days prior to the first administration of the study drug (Day1 of Cycle1). If the urine pregnancy test is inconclusive, a blood pregnancy test is required. Non-childbearing potential is defined as being post-menopausal for at least one year, surgically sterilized, or having undergone a hysterectomy;
- All subjects (both male and female) at risk of conception must agree to use a highly effective method of contraception with a failure rate of less than1% throughout the treatment period and for120 days (or180 days) after the last administration of the study drug.
Who cannot join
- Pathology of small cell lung cancer (SCLC), including mixed SCLC and NSCLC;
- Stage I and IV NSCLC, patients who have previously received systemic antitumor treatments such as immunotherapy, targeted therapy, or chemotherapy;
- Stage III unresectable NSCLC patients;
- Patients with rare EGFR mutations;
- Diagnosis of any malignancy other than NSCLC within5 years prior to the first dose, excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been surgically cured;
- Currently participating in an interventional clinical study or having received other investigational drugs or device therapies within4 weeks prior to the first dose;
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- Use of traditional Chinese medicine or immunomodulatory drugs with indications for NSCLC within2 weeks prior to the first dose (including thymosin, interferon, interleukin, except for local use to control pleural effusion);
- Active autoimmune disease requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within2 years prior to the first dose; replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment;
- Systemic corticosteroid therapy (excluding nasal, inhaled, or other local routes of corticosteroid administration) or any other form of immunosuppressive therapy within7 days prior to the first dose; Note: Physiological doses of corticosteroids (≤10 mg/day of prednisone or equivalent) are permitted;
- Clinically uncontrollable pleural effusion/ascites (subjects who do not require drainage or whose effusion does not significantly increase after stopping drainage for3 days may be enrolled);
- Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known allergy to study drugs such as sintilimab, pemetrexed, carboplatin, their active ingredients, or excipients;
- Inadequate recovery from toxicity and/or complications from any prior intervention before starting treatment (i.e., ≤ Grade1 or back to baseline, excluding fatigue or alopecia);
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV1/2 antibodies);
- Untreated active hepatitis B (defined as positive for HBsAg and detected HBV-DNA copy number exceeding the upper limit of normal of the testing laboratory at the study center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled: a) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, and the subject should receive anti-HBV treatment throughout the chemotherapy period to prevent viral reactivation; b) For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary;
- Active HCV infection (positive for HCV antibodies and HCV-RNA levels above the detection limit);
- Vaccination with a live vaccine within30 days prior to the first dose (Day1, Cycle1); Note: Administration of an injectable inactivated virus vaccine for seasonal influenza is allowed within30 days prior to the first dose, but administration of a live attenuated influenza vaccine via nasal route is not permitted;
- Pregnant or breastfeeding women;
- Presence of any severe or uncontrolled systemic disease, such as: a) Significant and symptomatically severe abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation; b) Unstable angina, congestive heart failure, chronic heart failure of NYHA class ≥2; c) Myocardial infarction within6 months prior to enrollment; d) Uncontrolled blood pressure (systolic >140 mmHg, diastolic >90 mmHg); e) History of non-infectious pneumonia requiring corticosteroid treatment within1 year prior to the first dose, or current clinically active interstitial lung disease; f) Active pulmonary tuberculosis; g) Active or uncontrolled infection requiring systemic treatment; h) Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction; i) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; j) Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L); k) Urinalysis indicating proteinuria ≥++, and confirmed24-hour urinary protein quantification >1.0 g; l) Presence of psychiatric disorders that may interfere with treatment compliance;
- Any history, disease evidence, treatment, or laboratory test abnormalities that might interfere with the results of the trial, hinder full participation in the study, or other conditions deemed inappropriate for enrollment by the investigator, or potential risks considered by the investigator as unsuitable for participation in this study.
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
241, West Huaihai Road, Shanghai
Shanghai, Shanghai Municipality, 200030
Bo Zhang, MD, +86-021-22200000, zb1063253078@163.com
About this study
Official title: A Phase II Single-Center Exploratory Study on the Efficacy and Safety of Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant Stage II-IIIB Non-Squamous Non-Small Cell Lung Cancer Patients
This study is a prospective, single-arm, single-center Phase II trial, aiming to investigate efficacy and safety of neoadjuvant chemotherapy sequentially combined with sintilimab in resectable EGFR-mutant stage II-IIIB non-squamous NSCLC patients
Read the detailed description
Previous studies have confirmed the efficacy of neoadjuvant chemotherapy and immunotherapy in NSCLC patients without driver gene mutations, while their effectiveness in patients with driver gene mutations remains controversial. This study is a prospective, single-arm, single-center Phase II trial targeting eligible subjects with resectable EGFR-mutated stage II-IIIB non-squamous non-small cell lung cancer, aiming to evaluate the efficacy and safety of sintilimab combined with chemotherapy as neoadjuvant therapy.
Eligible subjects who meet the inclusion criteria and have signed the informed consent will receive sintilimab in combination with chemotherapy, with a treatment cycle of 3 weeks. A tumor assessment will be conducted before the start of the third cycle of treatment, and surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant therapy, with a tumor assessment conducted 7 days prior to surgery. After completing local treatment (surgery), researchers will offer optional adjuvant therapy to patients, including EGFR-TKI. Concurrently, dynamic blood samples will be collected before neoadjuvant therapy and after each treatment cycle for exploratory analysis, with the evaluation of MPR and pCR based on circulating tumor DNA minimal residual disease (ctDNA-MRD).
- Conditions
- Lung Cancer
- Being tested
- Pemetrexed 500 mg/m2, carboplatin, Sintilimab
- Keywords
- NSCLC, EGFR, Neoadjuvant, Chemotherapy, PD-1
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed 500 mg/m2Drug
- Pemetrexed: 500mg/m² on Day 1, Q3W, administered via intravenous infusion for a total of 3 cycles.
carboplatinDrug
AUC=5 on Day 1, Q3W，administered via intravenous infusion for a total of 3 cycles.
SintilimabDrug
Sintilimab, 200mg, administered via intravenous infusion on the 3rd day of each cycle, Q3W, for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Resectable EGFR-Mutant Stage II-IIIB Non-Squamous Non-Small Cell Lung Cancer Patients. Eligible subjects who meet the inclusion criteria and have signed the informed consent will receive sintilimab in combination with chemotherapy, with a treatment cycle of 3 weeks. A tumor assessment will be conducted before the start of the third cycle of treatment, and surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant therapy, with a tumor assessment conducted 7 days prior to surgery. After completing local treatment (surgery), researchers will offer optional adjuvant therapy to patients, including EGFR-TKI. Receives: Drug: Pemetrexed 500 mg/m2; Drug: carboplatin; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathological response (MPR)
MPR is defined as ≤10% residual viable tumor cells in the lung and lymph nodes, to be evaluated within 2 weeks post-surgery.
Measured: Evaluated within 2 weeks post-surgery.
Secondary outcomes (2)
Pathological Complete Response (pCR)
pCR is defined as the absence of residual tumor in both the lung and lymph nodes after neoadjuvant therapy
Measured: Evaluated within 2 weeks post-surgery.
Event-Free Survival (EFS)
EFS is defined as the time from the start of neoadjuvant therapy to the occurrence of any disease progression that precludes surgery, post-surgical disease progression or recurrence, disease progression without surgery, or death from any cause. It is measured from the start of neoadjuvant therapy to the first recorded date of disease progression or death (whichever occurs first).
Measured: up to 3 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start31 Mar 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2028 (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.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhong, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688656
- Sponsor's protocol ID
- IS24145
- Acronym
- Peri-E
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Center Exploratory Study on the Efficacy and Safety of Neoadjuvant Chemotherapy Sequentially Combined with Sintilimab in Resectable EGFR-Mutant Stage II-IIIB Non-Squamous Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06688656
- Acronym / sponsor ID
- Peri-E / IS24145
- Conditions
- Lung Cancer
- Keywords
- NSCLC, EGFR, Neoadjuvant, Chemotherapy, PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Nov 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.
This study is a prospective, single-arm, single-center Phase II trial, aiming to investigate efficacy and safety of neoadjuvant chemotherapy sequentially combined with sintilimab in resectable EGFR-mutant stage II-IIIB non-squamous NSCLC patients
Detailed description
Previous studies have confirmed the efficacy of neoadjuvant chemotherapy and immunotherapy in NSCLC patients without driver gene mutations, while their effectiveness in patients with driver gene mutations remains controversial. This study is a prospective, single-arm, single-center Phase II trial targeting eligible subjects with resectable EGFR-mutated stage II-IIIB non-squamous non-small cell lung cancer, aiming to evaluate the efficacy and safety of sintilimab combined with chemotherapy as neoadjuvant therapy.
Eligible subjects who meet the inclusion criteria and have signed the informed consent will receive sintilimab in combination with chemotherapy, with a treatment cycle of 3 weeks. A tumor assessment will be conducted before the start of the third cycle of treatment, and surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant therapy, with a tumor assessment conducted 7 days prior to surgery. After completing local treatment (surgery), researchers will offer optional adjuvant therapy to patients, including EGFR-TKI. Concurrently, dynamic blood samples will be collected before neoadjuvant therapy and after each treatment cycle for exploratory analysis, with the evaluation of MPR and pCR based on circulating tumor DNA minimal residual disease (ctDNA-MRD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: Pemetrexed 500 mg/m2, Drug: carboplatin, Drug: SintilimabResectable EGFR-Mutant Stage II-IIIB Non-Squamous Non-Small Cell Lung Cancer Patients. Eligible subjects who meet the inclusion criteria and have signed the informed consent will receive sintilimab in combination with chemotherapy, with a treatment cycle of 3 weeks. A tumor assessment will be conducted before the start of the third cycle of treatment, and surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant therapy, with a tumor assessment conducted 7 days prior to surgery. After completing local treatment (surgery), researchers will offer optional adjuvant therapy to patients, including EGFR-TKI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Sign a written informed consent prior to any study-related procedures;
- Be aged ≥18 years;
- Have a histopathologically confirmed diagnosis of stage II-IIIB (N2) non-squamous NSCLC, as per the9th edition TNM staging system by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer, with suspected N2 disease confirmed via mediastinoscopy or EBUS;
- Have histologically, cytologically, or hematologically confirmed presence of EGFR-sensitive mutations (Ex19del, L858R), with co-existing driver mutations allowed;
- Have sufficient tissue samples for PD-L1 immunohistochemistry and NGS mutation testing; if tissue samples are inadequate, consent to undergo blood NGS testing;
Key exclusion criteria (20 listed)
- Pathology of small cell lung cancer (SCLC), including mixed SCLC and NSCLC;
- Stage I and IV NSCLC, patients who have previously received systemic antitumor treatments such as immunotherapy, targeted therapy, or chemotherapy;
- Stage III unresectable NSCLC patients;
- Patients with rare EGFR mutations;
- Diagnosis of any malignancy other than NSCLC within5 years prior to the first dose, excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been surgically cured;
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 |
|---|---|---|
| Pemetrexed 500 mg/m21. Pemetrexed: 500mg/m² on Day 1, Q3W, administered via intravenous infusion for a total of 3 cycles. | Drug | Arm 1 |
| carboplatinAUC=5 on Day 1, Q3W，administered via intravenous infusion for a total of 3 cycles. | Drug | Arm 1 |
| SintilimabSintilimab, 200mg, administered via intravenous infusion on the 3rd day of each cycle, Q3W, for a total of 3 cycles. | Drug | Arm 1 |
Primary outcome
major pathological response (MPR)
Time frame: Evaluated within 2 weeks post-surgery.
MPR is defined as ≤10% residual viable tumor cells in the lung and lymph nodes, to be evaluated within 2 weeks post-surgery.
2 secondary outcomes
Pathological Complete Response (pCR)
Time frame: Evaluated within 2 weeks post-surgery.
Event-Free Survival (EFS)
Time frame: up to 3 years after enrollment
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 14 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 Pemetrexed 500 mg/m2, carboplatin and Sintilimab in people with Lung Cancer, run by Shanghai Chest Hospital 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 14 inclusion and 20 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: opening soon, as of the sponsor's last update on 14 Nov 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?
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 Zhang Bo, MD (+86-021-22200000, zb1063253078@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major pathological response (MPR) (time frame: Evaluated within 2 weeks post-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 14 Nov 2024.