Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Cisplatin

Mitogens

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Icotinib 125 mg TID plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)

Icotinib

Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.

Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles

Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 2 cycles

NAN Wu, M.D.

NAN Wu

This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer

A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

A Phase II, Single-Arm, Prospective Study of Neoadjuvant Icotinib With Chemotherapy for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable for Stage II to IIIB(N2) Non-small Cell Lung Cancer

Monitor the change of plasma EGFR mutation copy number before neoadjuvant therapy, cycle 2 chemotherapy and pre-surgery.

The reduction degree of SUVmax in primary tumor and metastatic lymph nodes before and after neoadjuvant therapy was detected by PET-CT.

Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery

Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery

Defined as the time from the date of entry to the date of death from any cause.

DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.

ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.

DCR is defined as the percentage of participants having a complete response , a partial response and disease stability measured by RECIST 1.1.

the proportion of resection margin without macroscopic or microscopic tumor residue (negative resection margin)

Peking University Cancer Hospital & Institute

Principal Investigator

Amino Acids

Osimertinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)

Matching placebo for osimertinib, orally, once daily

The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease recurrence, unacceptable toxicity or other discontinuation criteria are met.

Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.

Placebo

AstraZeneca Clinical Study Information Center

Jonathan Goldman, MD

Yasuhiro Tsutani, MD, PhD

Jie He, MD, PhD

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour resection. All participants must have had a tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

Eligible participants will be randomised in a 1:1 ratio to one of the 2 intervention arms: osimertinib 80 mg or matching placebo, once daily for 3 years unless discontinuation criteria is met.

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib Versus Placebo in Participants With EGFR Mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, Following Complete Tumour Resection

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.

Stratification to the high risk stratum will be based on pathologic features assessed by central pathology review during screening.

DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.

OS is defined as the time from the date of randomisation until death due to any cause.

Ratio of metabolite-to-osimertinib to be calculated at predose, and at 0.5-2 hours postdose.

Assess the impact of osimertinib versus placebo on physical functioning in both the high-risk stratum and the overall population as measured by SF-36 V2 health survey

CNS DFS is defined as the time from randomisation to the time of a CNS lesion (as assessed by investigator) or death due to any cause, regardless of whether the participant withdraws from study intervention or receives other anti-cancer therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer	NCT05104788	Non-Small Cell ...	Icotinib Cisplatin Carboplatin Pemetrexed	18 Years - 75 Years	Peking University Cancer Hospital & Institute
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection	NCT05120349	Non-Small Cell ...	Osimertinib Placebo	18 Years -	AstraZeneca
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection	NCT05120349	Non-Small Cell ...	Osimertinib Placebo	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for egfrm positive