NCT05383716Active, not recruitingPhase 2
Neoadjuvant/Adjuvant Pembrolizumab Plus Chemotherapy
A Prospective, Single-arm PhaseⅡTrial of Neoadjuvant/Adjuvant Pembrolizumab Plus Platinum-doublet Chemotherapy (Chemo) in IIa-IIIb NSCLC
Source: ClinicalTrials.gov · Last updated 23 Apr 2024
Brief summary (registry, in English)
A phase II, single-arm, open-label study evaluating feasibility, safety and efficacy of combined chemotherapy and pembrolizumab as neoadjuvant/adjuvant therapy in stage IIa-IIIB NSCLC adult patients followed by adjuvant PD-(L)1 inhibitor treatment for up to 1 year
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 17 May 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 8 Dec 2023
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05383716
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 1 Jul 2022 to the primary completion date, 8 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having any uncontrolled systemic diseases, including active infection, uncontrolled hypertension, diabetes, unstable angina, congestive heart failure, acte myocardial infarction (within 3 months before treatment), serious arrhythmia requiring drug treatment, liver, kidney and metabolic diseases
Other illness
- Active, known or suspected autoimmune disease.
- Other active malignancy in the last 5 years (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast).
- History of allergy to study drug components excipients
Lab values
- Carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or other known targetable driver mutations.
- Prior treatment with anti-PD-1, anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen (CTLA-4), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Other
- Women in pregnancy or lactation
Who the study is looking for
- Primary non-small cell lung cancer (NSCLC) confirmed by cytology or histology
- Stage IIa to selected IIIb ( t1-4, n0-2 ) NSCLC according to the TNM stage (8th Edition) of IASLC, which is considered to be resectable;
- At least one evaluable focus judged according to RECIST 1.1 standard (on spiral CT, the longest diameter of tumor should be at least 10 mm, the shortest diameter of metastasis lymphnode should be at least 20 mm)
- ECOG PS 0 or 1
- Adequate tumor samples available for gene detection (EGFR/ALK /ros1) with non-squamous and specimens for PD-L1 immunohistochemistry (IHC) in all the subjects.
- Male or female, ≥ 18 years old
- Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 / L, platelet count ≥ 100 × 109 / L and hemoglobin 110 ≥ 9 g / dl
- Adequate liver function: total bilirubin ≤ upper limit of normal value (ULN); AST and alt ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN)
- Adequate renal function: serum creatinine ≤ upper limit of normal value (ULN) or calculated creatinine clearance ≥ 60ml / min
- No history of using anti-tumor drug treatment before
- For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of study treatment, and the patients have recovered
- Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.