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Non Small Cell Lung CancerPhase 1/2GOALNCT01513174

Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone

A Phase 1/2 study testing Gefitinib and Olaparib in people with Non Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 5 sites in Spain.

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 is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Gefitinib and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
5 sitesSpain
Study dates
Aug 2011to Jul 2016
Phase
Phase 1/2
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

  • Patients age 18 years or more.
  • Histologically confirmed diagnosis of non-small-cell lung carcinoma.
  • Stage IV disease, following the Seventh Edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual (27).
  • Tumor tissue available (according to the criterion of the specimen-processing laboratory) for EGFR mutation assessment: to be included in the study patients should present at least one EGFR mutation (exon 19 deletion or L858R with or without T790M).
  • Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
  • ECOG score ≤ 2.
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  • Life expectancy of ≥ 3 months.
  • For the Phase II part of the study, patients should not have received previous treatment with chemotherapy or other agents for advanced disease: chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment, as long as a minimum of 6 months has passed since the end of the adjuvant and/or neo-adjuvant chemotherapy. This criterion is not mandatory to patients to be included in the Phase I part of the study (these patients are allowed to have received a prior line of treatment for advanced disease).
  • Patients with the following hematologic values:
  • Absolute Neutrophil Count (ANC) ≥1.5 x 109/L
  • Hemoglobin (Hb) ≥ 10 g/dl
  • Platelets ≥ 100 x 109/L
  • Patients with the following biochemical values:
  • Bilirubin ≤ 1.5 mg/dL
  • Aspartate aminotransferase (AST) and Alanine transaminase (ALT) < 1.5 upper limit of normality
  • Creatinine clearance ≥ 60 ml/min.
  • Patients of childbearing age of either sex must use effective contraceptive methods(barrier methods plus other birth control methods) before entering the study and while participating in the study.
  • Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
  • Patients must be available for clinical follow-up.

Who cannot join

  • Patients diagnosed of another neoplasm, with the exception of cervical carcinoma insitu, treated squamous cell carcinoma or superficial bladder tumor (Ta and TIS), or other malignant tumors that have received curative treatment within the last 5 years before inclusion in the study.
  • Simultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.
  • Patients with HIV infection, HCV infection, coronary disease or uncontrolled arrhythmia, uncontrolled cerebrovascular disease and other clinical conditions that, in the judgment of the investigator, contraindicate the patient's participation in the study.
  • Past medical history of interstitial lung disease (ILD), drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.
  • Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline.
  • Uncontrolled seizures.
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  • Patients considered requiring radiotherapy to the lung at the time of study entry or in the near future.
  • Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication.
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Patients who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test performed within 7 days before the onset of treatment(Appendix 8).
  • Patients receiving the following classes of inhibitors of CYP3A4 (see Appendix 5 for guidelines and wash out periods):
  • Azole antifungals
  • Macrolide antibiotics
  • Protease inhibitors
  • Concomitant use of known CYP3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
  • Major surgery within 2 weeks of starting study treatment; patients must have recovered from any effects of any major surgery.
  • Significant weight loss (= 10% of body weight) in the 6 weeks before inclusion in the study.
  • Any condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study.
  • Substance abuse or clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance.
  • Patients who present any contraindication or suspected allergy to the products under investigation in the study. Tablets of gefitinib contain lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose and galactose malabsorption, will not be included in this trial.
  • Contraindication for steroid use.
  • Impossibility to comply with treatment due to cultural or geographic circumstances.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • H. Teresa Herrera

    A Coruña

  • H. Gen. Universitario de Alicante

    Alicante

  • H. Germans Trias i Pujol

    Badalona, Barcelona

  • H. Vall d'Hebrón

    Barcelona

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

Other trials in Spain

About this study

Official title: Multicenter, Randomized, Phase Ib/IIb Study to Evaluate the Efficacy and Tolerability of Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone, in Patients With EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer.

Read the detailed description

GOAL is a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.

Being tested
Gefitinib, Olaparib
Keywords
GOAL, Lung, Non small cell lung cancer, EGFR mutations
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.

  • GefitinibDrug

    Also called Iressa

    Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression

  • OlaparibDrug

    Also called Lynparza

    Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase Ib study) twice a day, continuously, in 28-day cycles.

Study groups in NCT01513174
Study groupRoleWhat they receive
Control GefitinibActive comparatorGefitinib will be administered once daily, continuously, in 28-day cycles, as a fixed dose of 250 mg/day.
Receives: Drug: Gefitinib
Experimental: Gefitinib in combination with olaparibExperimentalGefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase I study) twice a day, continuously, in 28-day cycles.
Receives: Drug: Gefitinib; Drug: Olaparib

What is being measured

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

  1. Progression-free Survival (PFS)

    Defined as the length of time from the date of randomization to the date of the first documented progression of disease. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"

    Measured: From the date of randomization until end of follow up, up to 30 months.

Secondary outcomes (2)

  1. Overall Survival

    Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

    Measured: From the date of randomization until end of follow up, up to 30 months

  2. Best Global Response During Treatment Period

    To evaluate the best global response of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Measured: From the date of randomization until end of follow up, up to 30 months

Timeline

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

  1. First posted20 Jan 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionJul 2016
  4. Study completionJul 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513174
Sponsor's protocol ID
GECP10-03_GOAL
Other IDs
2010-024178-21
Acronym
GOAL
Status last verified
Jan 2024
First submitted
11 Dec 2011
Last updated
28 Jun 2024
Data monitoring committee
Yes

Publications

  • Garcia-Campelo R, Arrieta O, Massuti B, Rodriguez-Abreu D, Granados ALO, Majem M, Vicente D, Lianes P, Bosch-Barrera J, Insa A, Domine M, Reguart N, Guirado M, Sala MA, Vazquez-Estevez S, Caro RB, Drozdowskyj A, Verdu A, Karachaliou N, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group (SLCG). Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL). Lung Cancer. 2020 Dec;150:62-69. doi: 10.1016/j.lungcan.2020.09.018. Epub 2020 Oct 3.

    PubMed 33070053

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gefitinib and Olaparib in people with Non Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 5 sites in Spain.

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 19 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: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 28 Jun 2024). 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) (time frame: From the date of randomization until end of follow up, up to 30 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 NCT01513174, 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 28 Jun 2024.

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