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Non Small Cell Lung CancerPhase 2CERTAINNCT02353741

Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC

A Phase 2 study testing EGFR-TKIs and thoracic radiotherapy in people with Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
EGFR-TKIs and thoracic radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
Apr 2015to 1 Dec 2018
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG performance status≤2；
  • Cytologically or pathologically confirmed stage IV NSCLC ( controlled pleural effusion will be eligible) with active EGFR mutation;
  • Estimated survival time more than 3 months;
  • Age older than 18 years and under 75 years;
  • Adequate bone marrow, hepatic, and renal function;AST and ALT≤2.5 times the highest reference value when not associated with hepatic metastases, or ≤5 times when hepatic metastases occur;
  • Without history of therapy for primary and metastatic disease;
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  • With pleural effusion but can be controlled;
  • Asymptomatic bone metastases without treatment;
  • Based on fusion images of 4DCT MIP sketch tumors and lymph nodes, and limit the mean lung dose: V20≤25%，V30≤18%，MLD≤14Gy，V5≤60%;
  • M1a or M1b for metastases, and the number of the distant lesions ≤10；
  • Voluntary to participate in this clinical trial and sign the consent form.

Who cannot join

  • Patients with serious functional damage of important organs;
  • Patients diagnosed adequately with other malignant tumors;
  • Pregnant or lactating women;
  • Patients in an active period of acute or chronic infectious diseases;
  • Patients who are allergic to any drugs or people with allergies;
  • With brain metastases;
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  • With bone metastases needing radiotherapy;
  • Patients who participate in other clinical trials concurrently;
  • Uncontrolled pleural effusion which may intervene the radiotherapy to primary tumor in lung;
  • The number of the distant lesions>10；
  • Patients who are considered not eligible for the trial after evaluation by investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xinqiao Hospital of Chongqing

    Chongqing, 400000

Other trials in China

About this study

Official title: Concurrent EGFR-TKIs and Thoracic Radiation Therapy in EGFR Active Mutation for the First Line Treatment of Non-Small Cell Lung Cancer at Stage IV: A Single-arm, Open-label, Single Center, Phase II Trial.

This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.

Read the detailed description

Based on NCCN guideline of the epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) such as erlotinib, gefitinib and icotinib as the first line treatment for advanced Non-Small Cell Lung Cancer (NSCLC), the efficacy of EGFR-TKIs in combination with thoracic radiotherapy as the first line treatment for stage IV NSCLC with active EGFR mutation remains unknown. In this single-arm phase II trial, we chose the subjects with stage IV harboring active EGFR mutation,who were treated by EGFR-TKIs combined with radiation therapy. The primary endpoint is 1-year rate of progression-free survival and the second endpoints are overall survival (OS), objective response rate and toxic and side effect. By evaluating them, we expect to find out the evidence that the combination therapy can benefit the short-term and long-term survival of the patients. Meanwhile, via the stratification analysis of tumor biomarker and immune index, we obtain the evidences for the benefits of comprehensive and individual treatment for advanced NSCLC.

Being tested
EGFR-TKIs, thoracic radiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EGFR-TKIsDrug

    Beginning on day 2 of treatment, receive oral erlotinib 150mg per day.

  • thoracic radiotherapyRadiation

    Also called thoracic radiation

    From the beginning of EGFR-TKIs, within 2 weeks, receive concurrent thoracic radiotherapy, pGTV54～60Gy/27～30f/5.5～6w.

Study groups in NCT02353741
Study groupRoleWhat they receive
EGFR-TKIs combined with radiotherapyExperimentalEGFR-TKIs combined with concurrent thoracic radiotherapy. Receive oral erlotinib 150mg per day with concurrent thoracic radiotherapy, within 2 weeks, pGTV54～60Gy/27～30f/5.5～6w.
Receives: Drug: EGFR-TKIs; Radiation: thoracic radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year rate of progression-free survival

    1-year rate of progression-free survival

    Measured: one year after treatment, followed

Secondary outcomes (6)

  1. Overall survival (OS)

    Overall survival (OS)

    Measured: From the time of study enrollment until the date of death

  2. Objective response rate

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: up to three years

  3. Disease control rate

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: up to three years

  4. patients quality of life

    Assessed by EORTC-QLQ C30

    Measured: up to three years

  5. Failure mode

    The number of patients who failed the treatment of EGFR-TKIs with thoracic radiotherapy.

    Measured: up to three years

  6. Toxicities associated with combined erlotinib and concurrent thoracic radiotherapy. Assessed by Common Terminology Criteria for Adverse Events(CTCAE)

    Assessed by Common Terminology Criteria for Adverse Events(CTCAE)

    Measured: up to three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJun 2018
  4. Study completion1 Dec 2018

Why it stopped: too slow of recruitmentc

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02353741
Sponsor's protocol ID
XQonc-001
Acronym
CERTAIN
Status last verified
Dec 2018
First submitted
16 Jan 2015
Last updated
21 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Zheng L, Wang Y, Xu Z, Yang Q, Zhu G, Liao XY, Chen X, Zhu B, Duan Y, Sun J. Concurrent EGFR-TKI and Thoracic Radiotherapy as First-Line Treatment for Stage IV Non-Small Cell Lung Cancer Harboring EGFR Active Mutations. Oncologist. 2019 Aug;24(8):1031-e612. doi: 10.1634/theoncologist.2019-0285. Epub 2019 Apr 30.

    PubMed 31040256

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EGFR-TKIs and thoracic radiotherapy in people with Non Small Cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.

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 11 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: stopped early, as of the sponsor's last update on 21 Dec 2018. 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 China. 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?

The study was stopped early (reason given: too slow of recruitmentc). 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?

1-year rate of progression-free survival (time frame: one year after treatment, followed). 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 NCT02353741, 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 21 Dec 2018.

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