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Osimertinib and Chemotherapy for EGFR-mutated Metastatic Lung Adenocarcinoma

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What is being tested

Osimertinib plus platinum doublet chemotherapy

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 80 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorThe University of Hong Kong
Study ContactJames CM Ho, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to explore a new treatment approach for patients with a specific type of lung cancer, known as metastatic EGFR-mutated lung adenocarcinoma. The study focuses on patients who traditionally have a poor prognosis. The goal is to determine how effective a combination of standard chemotherapy drugs (pemetrexed with either carboplatin or cisplatin) and a medication called osimertinib is in improving outcomes for these patients. This is important because finding better treatment methods could lead to longer survival and improved quality of life for individuals with this challenging condition. During the study, participants will first receive osimertinib and have their blood tested for specific cancer-related markers called EGFR mutations. After about three weeks of taking osimertinib, the blood test is repeated to see if there are changes in these markers. Participants who meet the criteria will then start chemotherapy within six weeks of beginning osimertinib. Researchers will track several outcomes, such as how long patients live without their disease getting worse and how well the cancer responds to treatment. The study also looks at how long patients continue the treatment and whether the cancer markers in the blood decrease, which could indicate a positive response to the therapy.

Official TitleReal-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma
NCT06918782
Principal SponsorThe University of Hong Kong
Study ContactJames CM Ho, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

47 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

10 inclusion criteria required to participate
Adults above 18 years old, both male and female;

Pathologically confirmed lung adenocarcinoma with stage IIIB/C or IV disease (TNM staging version 8);

Confirmed EGFR common sensitizing mutations (exon 21 L858R or exon 19 del) by locally approved molecular testing methods (allele-specific PCR or NGS) based on tumour tissues or plasma ctDNA;

Clinically decided for first-line systemic treatment with osimertinib;

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9 exclusion criteria prevent from participating
Mixed NSCLC and small cell carcinoma;

Prior systemic anticancer treatment (targeted therapy, chemotherapy or immunotherapy) for metastatic stage NSCLC;

Prior adjuvant chemotherapy or targeted therapy within 6 months;

Local radiotherapy within 2 weeks or major surgery within 4 weeks;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Incorporating chemotherapy with ongoing osimertinib treatment involves initiating osimertinib at the standard dose of 80mg orally once daily. This regimen includes a combination of pemetrexed and carboplatin or cisplatin administered intravenously every 3 weeks for a maximum of 6 cycles, followed by maintenance pemetrexed at a dosage of 500mg/m2 every 3 weeks in cases of non-progressive disease.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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Osimertinib and Chemotherapy for EGFR-mutated Metastatic Lung Adenocarcinoma | PatLynk