Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary: RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer.


Options:
A: Inclusion Criteria:

* More than 18 years of age
* Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
* At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
* ECOG PS 0-2
* At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
* Patients must have adequate hematologic, renal and liver function as defined by Hb \> 9g/dL, neutrophils \> 1000/mm3, platelets \> 50,000/mm3, creatinine \< 2mg/dL, and AST (SGOT) and/or ALT (SGPT) \< 5 x UNL (upper normal limit).
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
* Written and voluntary informed consent understood, signed and dated.

Exclusion Criteria:

* Patients with tumor harboring EGFR mutation.
* Prior systemic therapy for NSCLC
* Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
* Symptomatic brain metastasis. Brain metastases stable \< 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
* Major surgery within 3 weeks prior to study enrollment.
* Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
* Severe medical illness or active infection that would impair the ability to receive gefitinib.
* Pregnancy or breast feeding.
B: Inclusion Criteria:

* Subjects with histologically or cytologically documented NSCLC.
* Locally advanced or metastatic NSCLC
* Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
* Eligible to receive treatment with the selected doublet-chemotherapy
* Central confirmation of T790M+ mutation status
* World Health Organization (WHO) performance status 0-1
* At least one lesion, not previously irradiated.

Exclusion Criteria:

* • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
* Treatment with more than one prior line of treatment for advanced NSCLC
* Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment
* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment
* Previous treatment with Osimertinib, or a 3rd generation EGFR TKI

For subjects who cross-over to Osimertinib:

* Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review.
* At least 14 days since last dose of platinum-based doublet chemotherapy
C: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:

  * Stage IIIB

    * Pleural fluid and/or supraclavicular nodes allowed provided patient is not eligible for consolidation radiotherapy
  * Stage IV disease
* No disease progression after 2-6 courses of prior platinum-containing first-line palliative induction chemotherapy
* Brain metastases allowed provided patients are asymptomatic after cranial irradiation completed at least 4 weeks ago

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Pulmonary

* No history, signs, or symptoms of clinically active interstitial lung disease

  * Patients with chronic, stable, asymptomatic radiographic changes are eligible

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
* No other malignant disease within the past 5 years except basal cell skin cancer or adequately treated superficial carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunotherapy

Chemotherapy

* See Disease Characteristics
* Recovered from prior chemotherapy (alopecia allowed)
* No concurrent chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics

Surgery

* Not specified

Other

* No prior epidermal growth factor receptor inhibitors
* No concurrent administration of any of the following drugs:

  * Phenytoin
  * Carbamazepine
  * Rifampin
  * Phenobarbital
  * Hypericum perforatum (St. John's wort)
* No other concurrent anticancer therapy
* No other concurrent experimental drugs
D: Inclusion Criteria:

* Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
* Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
* Patients with documented 'acquired resistance' on first line gefitinib
* Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
* Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

* Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). Palliative bone radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity).
* Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer
* Any evidence of severe of uncontrolled systemic disease Treatment with an investigational drug within 4 weeks before randomization

Answer: C