Study with erlotinib compared to intercalated erlotinib with cisplatinum pemetrexed for advanced lung cancer

Phase 1

• Conditions: Advanced non-small cell lung cancer; MedDRA version: 19.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004303-39-NL
• Lead Sponsor: Stichting NVALT Studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-21
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Histologically or cytologically confirmed non-squamous NSCLC locally advanced and metastatic disease stage IIIB and stage IV disease.
2.At least 10 slides of tumor tissue, as determined by local pathologist, available for additional research questions
3.Tumor treatment-naive NSCLC patients.
4.Documented activating EGFR mutation in exon 18, 19 or exon 21.
5.At least one unidimensionally measurable lesion meeting RECIST1.1 criteria.
6.ECOG PS 0-3
7.Age > 18 years
8.Adequate organ function, including:
a.Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
b.Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 3.0 x ULN
AP, ALT, and AST <5 xULN is acceptable if the liver has tumor involvement
c.Renal: calculated creatinin clearance > 40 ml/min based on the Cockroft-Gault formula.
9.Signed informed consent
10.Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
11.Estimated life expectancy >12 weeks
12.Patient compliance.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

1.Pregnant or lactating women
2.Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection.
3.Documented symptomatic brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
4.Concomitant treatment with any other experimental drug under investigation.
5.Concomitant treatment with potent CYP3A4 inhibitor, such as ketoconazole, itraconazole, voriconazole, or protease inhibitors, erythromycin or clarithromycin or CYP3A4 inducers such as phenytoin, carbamazepine, barbiturates or St. Johns Wort.
6.Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
7.Previous cytotoxic chemotherapy for lung cancer less than 2 years before study entry.
8.For curatively treated lung cancer: (adjuvant) chemotherapy or chemo-radiotherapy less than 12 month prior to the study entry.
9.Previous or active concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 2 years prior to study entry.
10.History of HIV infection or chronic hepatitis B or C
11.Active clinically serious infection
12.Severe co-morbidity.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare progression-free survival (PFS) between erlotinib alone and cisplatin-pemetrexed-erlotinib in patients with EGFR mutated NSCLC locally advanced and metastatic disease stage IIIB and IV.;Secondary Objective: To characterize toxicities of both treatment regimen, tumor response, quality of life, duration of tumor response and overall survival and correlate baseline cMet status with overall survival. ;Primary end point(s): Disease progression;Timepoint(s) of evaluation of this end point: Continuously

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Adverse events<br>2. Tumor response<br>3. Quality of life<br>4. Death;Timepoint(s) of evaluation of this end point: 1. Continuously<br>2. Every 6 weeks<br>3. Every 12 weeks<br>4. Continuously