Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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Osimertinib

Carboplatin

Pemetrexed

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Vitamin B Complex

Folic Acid Antagonists

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

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Folate

Vitamin B9

Tyrosine

osimertinib 80 mg po qd plus pemetrexed 500 mg/m2 and carboplatin area under curve 5 intravenously every 3 weeks for four cycles, followed by maintenance osimertinib and pemetrexed until disease progression

osimertinib 80 mg po qd until disease progression

Osimertinib 80 MG [Tagrisso]

pemetrexed 500 mg/m2 intravenously every 3 weeks until disease progression

Pemetrexed 500 MG Injection

carboplatin area under curve 5 intravenously every 3 weeks for four cycles

This is a phase III clinical trial aimed to compare the efficacy and safety of Osimertinib monotherapy and combination of Osimertinib, pemetrexed and carboplatin in untreated patients with advanced non-small cell lung cancer with concurrent EGFR and TP53 mutation.

This is a multicenter, randomized, open label, phase III study comparing the progression free survival, overall survival, response rate, toxicity, quality of life between Osimertinib monotherapy and combination of osimertinib, pemetrexed, carboplatin in first-line treatment of advanced non-small cell lung cancer patients with concurrent EGFR and TP53 mutation. Besides, the association between other genetic mutations and efficacy will also be analyzed as exploratory endpoint. Eligible patients will be randomized to receive either osimertinib or osimertinib combined with pemetrexed and carboplatin in a 1:1 ratio.

Phase III Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib,Carboplatin and Pemetrexed for Untreated Patients With Advanced Non-squamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations

These biomarkers will be assessed by next generation sequencing of tumor tissue or peripheral blood

defined as the time from randomization to the date of first documentation of from date of randomization until the date of first documented progression or date of death from any cause, whichever came first

from date of randomization until the date of death from any cause

Overall incidence of AEs; the incidence of grade 3 or above AEs; the incidence of severe adverse events (SAE); the incidence of drug-related AEs; the incidence of AEs resulting in permanent withdrawal of drugs; the incidence of AEs leading to dose adjustment

The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life \[QoL\]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week." Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib,Carboplatin and Pemetrexed for Untreated Patients With Advanced Non-squamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations	NCT04695925	Non-small Cell ... EGFR Gene Mutat...	Osimertinib 80 ... Pemetrexed 500 ... Carboplatin	18 Years -	Sun Yat-sen University
Phase III Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib,Carboplatin and Pemetrexed for Untreated Patients With Advanced Non-squamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations	NCT04695925	Non-small Cell ... EGFR Gene Mutat...	Osimertinib 80 ... Pemetrexed 500 ... Carboplatin	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for osimertinib 80 mg [tagrisso]