NCT05132985Not yet recruitingPhase 2
Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma
Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study
Source: ClinicalTrials.gov · Last updated 10 Dec 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 14 Nov 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Diseases
- Lung cancer
- NCT number
- NCT05132985
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 1 Jan 2022 to the primary completion date, 1 Jul 2024
- 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.
Other illness
- Mixed small cell and non-small-cell lung cancer histology
- T4 tumors infiltrating the aorta, esophagus and/or heart
- Bulky N2 disease
- Medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD
- Severe or uncontrolled systemic diseases/active infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy
Lab values
- Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy
- EGFR-TKI-sensitizing mutations with T790M
Other
- Candidates for segmentectomies or wedge resections only
Who the study is looking for
- Written informed consent
- Male or female, aged ≥18 years and ≤75 years
- Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology)
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation
- A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone
- ECOG PS 0/1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
- Adequate organ and marrow function as defined by:
- Hemoglobin: ≥9.0 g/dL
- Absolute neutrophil count: ≥1.5 × 109/l
- Platelet count: ≥100 × 109/l
- Serum bilirubin: ≤1.5 ULN
- ALT and AST: ≤2.5 × ULN
- Creatinine clearance: ≥60 ml/min
- Life expectancy of 6 months prior to randomization
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.