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Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR Mutations | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR Mutations

Randomized, Open-label, Controlled Multicenter Study to Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Chinese NSCLC Patients Harbouring Activating EGFR Mutations(Artemis)

NCT02759614•Guangdong Association of Clinical Trials

View on ClinicalTrials.gov

Summary

Detailed Description

This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be randomly assigned to treatment group (1:1) through a dynamic randomization process with use of the following stratification factors: sex (female/male), disease stage (stage IIIb vs. stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R). An independent review committee (IRC) will be used to determine the response based study endpoints. IRC membership and procedures will be detailed in an IRC charter. A data safety monitoring board (DSMB) will be used in this study. DSMB is an independent body and will be responsible for reviewing safety data of the study. DSMB membership and procedures will be detailed in a separate DSMB document. Information regarding the nature and the duration of subsequent treatment will be collected.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet the following criteria for study entry:
•1. Signed Informed Consent Form.
•2. Age≥18 years.
•3. Able to comply with the study protocol, in the investigator's judgment.
•4. Histologically or cytologically documented inoperable, locally advanced (Stage IIIb who are not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous NSCLC. Diagnoses of non-squamous NSCLC based on sputum cytology alone are not acceptable.
•5. An exon 19 deletion mutation or exon 21 L858R mutation has been found in high-sensitivity EGFR mutation tests by PCR using tumor tissue centrally confirmed. Direct sequencing is not accepted.
•6. Eastern Cooperative Oncology Group performance status 0-1.
•7. Life expectancy≥12 weeks.
•8. Previous systemic cytotoxic chemotherapy for locally advanced, metastatic or recurrent disease has not been performed. Subjects who have undergone intracavity administration with an antineoplastic agent during pleurodesis are not permitted. For patients who have undergone pre- or postoperative adjuvant chemotherapy, at least 6 months have elapsed since the final administration date.
•9. Patients who have undergone radiotherapy may be enrolled if they meet the following conditions:
+16 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from study entry:
•1. Mixed adenosquamous carcinomas with predominantly squamous component.
•2. A positive result for the exon 20 T790M mutation from any high-sensitivity EGFR mutation test such as digital PCR using tumor tissue or cells.
•3. Evidence of CNS metastases, except for the patients without any symptom or the patients with symptom but have stable disease for at least 28 days after treatment of CNS metastases.
•4. History of haemoptysis, defined as \> 2.5 ml of red blood per event within 3 months prior to randomization.
•5. Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g., pulmonary artery or superior vena cava).
•6. Major surgery (including open biopsy) or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during study treatment.
•7. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device are excluded within 7 days prior to initiation of study treatment. Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.
•8. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (325 mg/day) or other nonsteroidal anti-inflammatory agents known to inhibit platelet function.
•9. Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
+18 more criteria

Locations (1)

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

Key Dates

Start Date

April 1, 2016

Primary Completion Date

June 1, 2018

Completion Date

March 30, 2020

Last Updated

March 13, 2026

Enrollment

311

ACTUAL participants

Conditions

NSCLC

Interventions

Bevacizumab

DRUG

Erlotinib

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITING

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

View study

RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR Mutations

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Magnetic Resonance Imaging of the Lung: Oncological Applications

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Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements