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Advanced NSCLC With EGFR MutationPhase 2NCT03457337

S-1 Plus Gefitinib Versus Gefitinib Monotherapy in Patients With EGFR-sensitive Mutation Advanced Non-squamous NSCLC

A Phase 2 study testing S-1 plus Gefitinib and Gefitinib in people with Advanced NSCLC With EGFR Mutation, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the survival benefit of first-line therapy for patients with EGFR-sensitive mutation-positive advanced non-squamous non-small cell lung cancer treated with S-1plus gefitinib versus gefitinib monotherapy Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced NSCLC With EGFR Mutation
What is being tested?
S-1 plus Gefitinib and Gefitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
28 Mar 2018to 31 Oct 2021
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

  • Volunteered for attending the study, and signed informed consent form (ICF)to participate in the study.
  • Males or females aged ≥18 years, < 75 years.
  • Cytologically and Histologically documented, advanced or recurrent (stage IIIc-IV) non-small cell lung cancer patients .
  • exon 19 deletion or exon 21 L858R for EGFR mutation.
  • Patients hadn't received past system treatment, including cytotoxic drugs; For patients who have received adjuvant or neoadjuvant chemotherapy appears recurrence or metastasis more than 6 months from accepting the last dose of chemotherapy drugs
  • Patients must have at least 1 measurable lesion according to the RECIST (version 1.1) criteria.
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  • Life expectancy ≥12 weeks.
  • ECOG performance status 0-2.
  • Adequate organ function as defined by the following criteria:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN), alkaline phosphatase (AP), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in the absence of liver metastases or up to 5 ULN in case of liver metastases.
  • creatinine clearance≥ 60 ml/min.
  • Fertile men and women must use effective contraception.
  • Subjects are allowed to receive radiation for lesions other than the target lesion, but the end of radiotherapy should be at least 3 weeks apart from randomization;
  • The investigators should judge the subject's compliance to meet the study requirements.

Who cannot join

  • Histology confirmed for squamous carcinomas, including mixed gland scale cancer, small cell lung cancer.
  • Patients with prior any anti-tumor therapy,including chemotherapy, radiotherapy, immunotherapy or biotherapy
  • Patients with prior exposure to EGFR-TKIs or 5-Fu
  • Not recovered from previous toxic reactions for anticancer treatment (CTCAE grade 1) or not fully recovered from previous surgery
  • Patients who have brain metastasis. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
  • Patients haven't been diagnosed other malignant disease, except the basal cell carcinoma and cervical carcinoma.
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  • A uncontrolled clinical infection, activity, including acute pneumonia,HIV,HCV. , etc.
  • Sullivudine, brivudine or other antiviral drugs of similar structure were used within 2 months before randomization
  • Patients who have a difficulty in swallowing or drug absorption.
  • Patients with a history of interstitial lung disease or with interstitial lung disease;
  • There are diseases of alimentary canal such as active duodenal ulcer, the ulcerous colitis, intestinal obstruction or other conditions which can cause gastrointestinal bleeding or perforation in the investigator's opinion; or patient has a history of intestinal perforation, intestinal fistula.
  • Evaluation of cardiac function: left ventricular ejection fraction < 50% (echocardiography); Moderate or above disorders of mitral valve and tricuspid shut down;, serious/unstable angina or acute myocardial infarction coronary artery bypass surgery in 6 months before enrollment; patients with class 2 and above cardiac dysfunction according to New York heart association (NYHA) classification
  • Patients with medical history of hemoptysis (defined as about 2.5ml bright blood) 2 weeks before the enrollments
  • Stroke and transient ischemic in 12 months before enrollment.
  • Severe ulcer in the skin wound, trauma and mucosa or fractures have been not fully healed.
  • Patients received CYP3A4 strong inhibitor and/or inducer in 2 weeks before enrollment; Patients received P-gp and breast cancer resistance protein (BCRP) substrates drug in 2 weeks before enrollment.
  • Patients has participated in other clinical trials of antitumor drugs within the previous 28 days, except for those who were able to prove that they were using placebo;
  • Pregnancy or lactating women or pregnant women may be pregnant before pregnancy test positive;
  • Unwillingness to receive contraception by patients or their sexual partners who are fertile but unwilling to receive contraception;
  • The investigators think that there is any clinical or laboratory abnormalities in the subjects that are not suitable for this study.
  • There is a serious psychological or mental abnormalities, researchers assess subjects to participate in this clinical study compliance is insufficient;
  • Allergic reactions to analogs of gefitinib and S-1 and / or Analogs and / or excipients in test drugs.

Trial locations and contacts

1 site in 1 country.

Qiming Wang, Ph.D contact

0086+13783590691

qimingwang1006@163.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Qiming Wang, doctor

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Controlled, Open-label, Prospective Trial of S-1 Plus Gefitinib Versus Gefitinib Monotherapy for First-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With EGFR-sensitive Mutation

To investigate the survival benefit of first-line therapy for patients with EGFR-sensitive mutation-positive advanced non-squamous non-small cell lung cancer treated with S-1plus gefitinib versus gefitinib monotherapy

Read the detailed description

This is a randomized, controlled, open-plan, prospective clinical study. According to the available evidence, we selected patients with locally advanced or metastatic non-squamous non-small cell lung cancer with stage Ⅲ-C-Ⅳ confirmed by cytology or histology and positive EGFR-sensitive mutation, then patients accept first-line treatment with S-1 plus gefitinib or gefitinib. This study will collect FFS during treatment until the patient dies and will follow the survival of the subject after the disease progresses.

Being tested
S-1 plus Gefitinib, Gefitinib

What participants receive

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

  • S-1 plus GefitinibDrug

    S-1: According to the body surface area (BSA) to determine the dose, twice daily, after breakfast and dinner orally Gefitinib: 250mg, 1 day, orally, fasting or with the same service

  • GefitinibDrug

    Gefitinib: 250mg, 1 day, orally

Study groups in NCT03457337
Study groupRoleWhat they receive
S-1 plus GefitinibExperimentalS-1: According to the body surface area (BSA) to determine the dose, twice daily, after breakfast and dinner orally, continuous administration of 14 days, rest for 7 days. BSA <1.25 m2, 80 mg / day; BSA 1.25 m2 to <1.5 m2, 100 mg / day; BSA 1.5 m2 or more, 120 mg / day. Until disease progression, intolerance of toxicity or withdrawal of informed consent from the subject. Gefitinib: 250mg, 1 day, orally, fasting or with the same service. Until disease progression, intolerance of toxicity or withdrawal of informed consent from the subject.
Receives: Drug: S-1 plus Gefitinib
GefitinibActive comparatorGefitinib 250 mg/day oral daily
Receives: Drug: Gefitinib

What is being measured

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

  1. Progression free survival(PFS)

    From start of anti-cancer therapy until progression or death.To evaluate the disease free survival of gefitinib combined with S-1 and gefitinib in patients with Pathological stage IIIc-IV NSCLC harbouring sensitive mutations of EGFR. Progression free survival (PFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.

    Measured: 2 years

Secondary outcomes (4)

  1. Overall survival(OS)

    To evaluate the overall survivalof gefitinib combined with S-1 and gefitinib in patients with Pathological stage IIIc-IV NSCLC harbouring sensitive mutations of EGFR in the 3 years since treatment begain

    Measured: 3 years

  2. Disease control rate

    To compare disease control rate of the two arms from start of anti-cancer therapy until progression

    Measured: 2 years

  3. Objective response rate(ORR)

    To compare objective response rate of the two arms from start of anti-cancer therapy until progression

    Measured: 2 years

  4. Number of Participants with Adverse Events

    The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of radiotherapy.

    Measured: 3 years

Timeline

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

  1. First posted7 Mar 2018
  2. Study start28 Mar 2018
  3. Primary completion31 Oct 2020 (estimated)
  4. Study completion31 Oct 2021 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03457337
Sponsor's protocol ID
NA-01
Status last verified
Apr 2020
First submitted
23 Feb 2018
Last updated
10 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S-1 plus Gefitinib and Gefitinib in people with Advanced NSCLC With EGFR Mutation, run by Henan Cancer Hospital 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 15 inclusion and 22 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 10 Jul 2020. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qiming Wang, Ph.D (0086+13783590691, qimingwang1006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS) (time frame: 2 years). 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 NCT03457337.

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 10 Jul 2020.

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