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Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01174563

A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

A Phase 2 study testing erlotinib [Tarceva] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 16 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Squamous Non-Small Cell Lung Cancer
What is being tested?
erlotinib [Tarceva]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
16 sitesIsrael
Study dates
23 May 2011to 20 Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants, >/= 18 years of age
  • Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small cell lung cancer (NSCLC)
  • Presence of epidermal growth factor receptor (EGFR) mutations
  • Previously untreated with any systemic anti-neoplastic therapy for advanced disease
  • Last dose of a prior systemic anti-neoplastic therapy for early-stage disease >/= 4 weeks before study start, and patient recovered from acute toxicities of any previous therapy
  • A life expectancy of at least 12 weeks
  • Able to comply with the study and its follow-up procedures
  • Female participants had to be postmenopausal (24 months of amenorrhea), surgically sterile or agree to use a physical method of contraception. Male participants had to be surgically sterile or agree to use a barrier method of contraception. Women with an intact uterus (unless amenorrhoeic for the last 24 months) had to have a negative pregnancy test (urine or serum) within 3 days prior to erlotinib treatment initiation in the study. Male and female participants had to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib. Acceptable methods of contraception included an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms)

Who cannot join

  • Pregnant or breast feeding women
  • Granulocyte count <1.5 x 109/L and platelet count <100*10^9/L
  • Serum bilirubin >1.5 upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 * ULN (or >5 * ULN if clearly attributable to liver metastasis)
  • Serum creatinine >1.5 ULN or creatinine clearance <60 mL/min
  • Known allergy or other adverse reaction to study drug or any other related compound
Show all 12Show fewer
  • Any significant unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease)
  • Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy)
  • Newly diagnosed or not yet definitively treated (i.e. stable disease >/= 2 months) CNS metastases or spinal cord compression
  • Any significant ophthalmological abnormality, especially those likely to increase the risk of corneal epithelial lesions (the use of contact lenses is not recommended during the study)
  • Participants who could not take oral medication, who required intravenous alimentation, had had prior surgical procedures affecting absorption, or had active peptic ulcer disease
  • Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Israel16 sites

  • Haemek Hospital; Oncology

    Afula, 18101

  • Barzilai; Oncology

    Ashkelon, 78278

  • Soroka Medical Center; Oncology Dept

    Beersheba, 8410101

  • Carmel Hospital; Oncology Unit

    Haifa, 34362

  • Rambam Medical Center; Oncology

    Haifa, 3525408

  • Wolfson Hospital; Oncology

    Holon, 58100

  • Shaare Zedek Medical Center; Oncology Dept

    Jerusalem, 91031

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 9112001

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Nahariya Hospital; Oncology

    Nahariya, 22100

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 5262100

  • Kaplan Medical Center; Oncology Inst.

    Rehovot, 7610001

  • Ziv Medical Center; Oncology Department

    Sefad, 13100

  • Sourasky / Ichilov Hospital; Oncology Department

    Tel Aviv, 64239-06

  • Poria Hospital; Oncology

    Tiberias, 15208

  • Assaf Harofeh; Oncology

    Tsrifin, 6093000

Other trials in Israel

About this study

Official title: A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy

This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.

Being tested
erlotinib [Tarceva]

What participants receive

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

  • erlotinib [Tarceva]Drug

    150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

Study groups in NCT01174563
Study groupRoleWhat they receive
Single ArmExperimentalNot described
Receives: Drug: erlotinib [Tarceva]

What is being measured

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

  1. Progression-free Survival (PFS) According to Grade of Rash

    PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

    Measured: Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Secondary outcomes (2)

  1. Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4

    Measured: Day 1 of treatment period until disease progression or death (approximately up to 67 months)

  2. Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4

    PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

    Measured: Day 1 of treatment period until disease progression or death (approximately up to 67 months)

Timeline

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

  1. First posted3 Aug 2010 (estimated)
  2. Study start23 May 2011
  3. Primary completion20 Dec 2016
  4. Study completion20 Dec 2016

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01174563
Sponsor's protocol ID
ML25200
Status last verified
Sep 2018
First submitted
2 Aug 2010
Last updated
17 Sep 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib [Tarceva] in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 16 sites in Israel.

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 8 inclusion and 12 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: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Israel. 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?

Yes. Results are posted in the registry (first posted 17 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (PFS) According to Grade of Rash (time frame: Day 1 of treatment period until disease progression or death (approximately up to 67 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 NCT01174563.

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 17 Sep 2018.

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