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Lung cancer drug cocktail shows promise in delaying tumor growth

NCT ID NCT02759614

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tested whether adding bevacizumab (Avastin) to erlotinib (Tarceva) works better than erlotinib alone for Chinese patients with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations. Over 300 patients were randomly assigned to one of the two treatment groups. The main goal was to see how long the cancer stayed under control (progression-free survival).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bevacizumab (Avastin) and erlotinib (Tarceva)
What this could lead to
If successful, this combination could offer a new first-line treatment option that delays cancer progression in patients with a specific type of lung cancer.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all lung cancer patients. Adding bevacizumab also increases the risk of side effects like high blood pressure or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

311 people

The number who actually took part.

Started

Apr 2016

Finished

Mar 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * The patient has no history of radiotherapy for lesions in lung fields within 28 days before the randomization. * For radiotherapy outside the chest region, at least 28 days have elapsed by the time of randomization since the final irradiation date. (if the radiotherapy given as palliation to bone metastases within 2 weeks, the patient should recovery from all toxicities) 10. Measurable disease at baseline. At least one lesion is present that can be measured in accordance with the criteria in Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. However, sites treated by radiotherapy should not be considered measurable. 11. Adequate haematological function: * Absolute neutrophil count (ANC)≥1.5×109/L AND * Platelet count≥100×109/L AND * Haemoglobin≥9 g/dL (may be transfused to maintain or exceed this level) 12. Adequate liver function. * Total bilirubin\<1.5×upper limit of normal (ULN) AND * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\<2.5×ULN in patients without liver metastases; \<5×ULN in patients with liver metastases 13. Adequate renal function * Serum creatinine≤1.5×ULN or calculated creatinine clearance≧45mL/min AND * Urine dipstick for proteinuria\<2+. Patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate≤1 g of protein in 24 hours. 14. International normalised ratio (INR)≤1.5 and partial prothrombin time (PTT or aPTT)≤1.5×ULN within 7 days prior to randomization. 15. For women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 6 months after the last dose of study drug. 16. For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 6 months after the last dose of study drug and agreement to refrain from donating sperm during this same period. 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. 10. History or evidence of inherited bleeding diathesis or coagulopathy that increases the risk of bleeding. 11. Uncontrolled hypertension (blood pressures: systolic\>150 mmHg and/or diastolic \>100 mmHg). 12. Prior history of hypertensive crisis or hypertensive encephalopathy. 13. Clinically significant (i.e., active) cardiovascular disease, including but not limited to cerebral vascular accident (CVA) or (transient ischemic attack) TIA (≤6 months before randomization), myocardial infarction (≤6 months before randomization), unstable angina, congestive heart failure New York Heart Association Class≥II, or serious cardiac arrhythmia requiring medication during the study and that might interfere with regularity of the study treatment or not controlled by medication. 14. Significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization. 15. Non-healing wound, active peptic ulcer, or bone fracture. 16. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment. 17. Pregnant or lactating, or intending to become pregnant during the study. 18. Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to randomization. 19. Known hypersensitivity to bevacizumab and Chinese hamster ovary cell products or other recombinant human or humanised antibodies or erlotinib or any of its excipients. 20. Evidence of ongoing or active infection requiring IV antibiotics; any other disease, neurological, or metabolic dysfunction; physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications. 21. Patients diagnosed with a tracheo-oesophageal fistula. 22. Prior chemotherapy or treatment with another systemic anti-cancer agent (e.g., monoclonal antibody, tyrosine kinase inhibitors, EGFR inhibitors, VEGF receptor inhibitors) for the treatment of the patient's current stage of disease (Stage IIIB not amenable for combined modality treatment, Stage IV or postoperative recurrent disease). NOTE: i. Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before randomization. 23. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active gastroduodenal ulcer disease. 24. Any inflammatory changes of the surface of the eye (e.g.: severe dry eye syndrome, keratoconjunctivitis, keratitis etc.) or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating oncologist and the ophthalmologist. 25. Patients with pre-existing Interstitial Lung Disease or pulmonary fibrosis. 26. Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Guangzhou, Guangdong, 510080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.