EGFR Positive Non-small Cell Lung CancerPhase 2AvaTaNCT03126799
A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+)
A Phase 2 study testing Erlotinib plus Bevacizumab and Erlotinib in people with EGFR Positive Non-small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- EGFR Positive Non-small Cell Lung Cancer
- What is being tested?
- Erlotinib plus Bevacizumab and Erlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2016to 20 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed stage IIIB \& IV non-small cell lung cancer other than squamous cell carcinoma
- Patients with one or more measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Locally diagnosed sensitive EGFR mutation positive (Exon 19 deletion or L858R)
- ECOG performance 0~1
- Age ≥ 19 years and - No previous treatment
- Adequate organ function by following:
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- ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL
- Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, If Liver metastasis, Serum bilirubin < 3 x UNL, AST (SGOT) and ALT (SGPT) < 5 x UNL
- Serum Cr ≤ 1 x UNL
- Patients who have had undergone radiotherapy are acceptable if patients meet all of the following criteria:
- No history of irradiation to pulmonary tumor lesions.
- In case of palliative irradiation to bone lesions in lung: at least 12 weeks must have passed at the date of registration since the last irradiation of the sites.
- In case of irradiation to non-pulmonary sites: at least two weeks must have passed at the date of inclusion since the last irradiation of the sites
- At the time of registration, at least the following period has passed since last date of the prior therapy or procedure:
- Surgery(including exploratory/ examination thoracotomy): 4 weeks
- Pleural cavity drainage: 1 weeks
- Pleurodesis without anti-neoplastic agents (inclusive of BRM such as Picibanil): 2 week
- Biopsy accompanied by incision (including thoracoscopic biopsy): 2 week
- Procedure for trauma (exclusive of patients with unhealed wound): 2 weeks
- Transfusion of blood, preparation of hematopoietic factor: 2 week
- Puncture and aspiration cytology: 1 week
- Other investigational product: 4 weeks
- Written informed consent form
Who cannot join
- Previous history of malignancy within 3 years from study entry except treated non-melanomatous skin cancer, uterine cervical cancer in situ, or thyroid cancer
- Prior chemotherapy or systemic anti-cancer therapy for metastatic disease but postoperative adjuvant or neoadjuvant therapy of 6 months or more previously is allowed
- Patients who received previous treatment for lung cancer with drugs
- Symptomatic or uncontrolled central nervous system (CNS) metastases
- Patients with increased risk of bleeding, clinically significant cardiovascular diseases, a history of thrombosis or thromboembolism in the 6 months prior to treatment, gastrointestinal problems, and neurologic problems
- Any significant ophthalmologic abnormality
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- Pre-existing parenchymal lung disease such as pulmonary fibrosis
- Known allergic history of Erlotinib or Bevacizumab
- Interstitial lung disease or fibrosis on chest radiogram
- Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of Erlotinib Alone Versus Erlotinib Plus Bevacizumab for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations
Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients.
In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.
Read the detailed description
EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Erlotinib is combined with Antiangiogenesis agent, Bevacizumab. Even Korean and Japanese are classified as Asian based on location, the figure of Korean is more tended to Western people due to the dietary life in recent years. However the incidence rate of EGFR mutation positive patients in Korea is much higher than Western countries.
Therefore Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients.
In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.
- Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Being tested
- Erlotinib plus Bevacizumab, Erlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib plus BevacizumabDrug
Also called Tarceva plus Avastin
Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks
ErlotinibDrug
Also called Tarceva
Erlotinib 150mg, po, daily, Q weeks
| Study group | Role | What they receive |
|---|---|---|
| A: Erlotinib only | Active comparator | Standard therapy arm:
Erlotinib 150mg. po, qd, daily, q 3weeks Receives: Drug: Erlotinib |
| B: Erlotinib plus Bevacizumab | Experimental | Study treatment arm; Erlotinib 150mg, po. qd, daily, q 3weeks plus Bevacizumab 15mg/kg, iv, on D1, q 3weeks. Receives: Drug: Erlotinib plus Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 36 months.
Secondary outcomes (2)
ORR
Overall Response Rate
Measured: through study completion, and average of 2 years
OS
Overall Survival
Measured: From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Nov 2016
- Primary completion31 Dec 2021
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EGFR Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Roche Korea co.,Ltd.
- Responsible party
- Principal investigator, Ji-youn Han, National Cancer Center, Korea
- Investigators
- Ji-Youn Han, Ph.D, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126799
- Sponsor's protocol ID
- NCC-2016-0107
- Acronym
- AvaTa
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng Z, Qin Y, Liu Y, Zhang Y, Lu Y. Role of Antiangiogenic Agents Combined With EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-Analysis. Clin Lung Cancer. 2021 Jan;22(1):e70-e83. doi: 10.1016/j.cllc.2020.08.005. Epub 2020 Sep 18.
PubMed 33067126
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Erlotinib Alone Versus Erlotinib Plus Bevacizumab for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations
- ClinicalTrials.gov ID
- NCT03126799
- Acronym / sponsor ID
- AvaTa / NCC-2016-0107
- Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Roche Korea co.,Ltd.
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 20 Jul 2023 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients.
In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.
Detailed description
EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Erlotinib is combined with Antiangiogenesis agent, Bevacizumab. Even Korean and Japanese are classified as Asian based on location, the figure of Korean is more tended to Western people due to the dietary life in recent years. However the incidence rate of EGFR mutation positive patients in Korea is much higher than Western countries.
Therefore Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients.
In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Erlotinib only | Active comparator | Drug: ErlotinibStandard therapy arm: Erlotinib 150mg. po, qd, daily, q 3weeks |
| B: Erlotinib plus Bevacizumab | Experimental | Drug: Erlotinib plus BevacizumabStudy treatment arm; Erlotinib 150mg, po. qd, daily, q 3weeks plus Bevacizumab 15mg/kg, iv, on D1, q 3weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Pathologically confirmed stage IIIB \& IV non-small cell lung cancer other than squamous cell carcinoma
- Patients with one or more measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Locally diagnosed sensitive EGFR mutation positive (Exon 19 deletion or L858R)
- ECOG performance 0~1
- Age ≥ 19 years and - No previous treatment
Key exclusion criteria (11 listed)
- Previous history of malignancy within 3 years from study entry except treated non-melanomatous skin cancer, uterine cervical cancer in situ, or thyroid cancer
- Prior chemotherapy or systemic anti-cancer therapy for metastatic disease but postoperative adjuvant or neoadjuvant therapy of 6 months or more previously is allowed
- Patients who received previous treatment for lung cancer with drugs
- Symptomatic or uncontrolled central nervous system (CNS) metastases
- Patients with increased risk of bleeding, clinically significant cardiovascular diseases, a history of thrombosis or thromboembolism in the 6 months prior to treatment, gastrointestinal problems, and neurologic problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erlotinib plus BevacizumabAlso: Tarceva plus AvastinErlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks | Drug | B: Erlotinib plus Bevacizumab |
| ErlotinibAlso: TarcevaErlotinib 150mg, po, daily, Q weeks | Drug | A: Erlotinib only |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 36 months.
Progression Free Survival
2 secondary outcomes
ORR
Time frame: through study completion, and average of 2 years
OS
Time frame: From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 33067126Deng Z, Qin Y, Liu Y, Zhang Y, Lu Y. Role of Antiangiogenic Agents Combined With EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-Analysis. Clin Lung Cancer. 2021 Jan;22(1):e70-e83. doi: 10.1016/j.cllc.2020.08.005. Epub 2020 Sep 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji-Youn Han, Ph.D principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib plus Bevacizumab and Erlotinib in people with EGFR Positive Non-small Cell Lung Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.