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TERMINATEDPHASE3

Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma

A Randomized Phase III Study of Docetaxel Versus Intercalated Erlotinib Docetaxel Combination Therapy in Patients With Relapsed EGFR (Epidermal Growth Factor Receptor) Wild Type, ALK(Anaplastic Lymphoma Kinase) Negative Non Squamous Cell Carcinoma. (NVALT 18 Study)

NCT02775006•The Netherlands Cancer Institute

View on ClinicalTrials.gov

Summary

The objective of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma.

Detailed Description

The aim of this study is to investigate the effect of docetaxel monotherapy and the combination of docetaxel intercalated erlotinib in patients with relapsed EGFR wild type, ALK negative non squamous cell carcinoma. As pemetrexed is standard first line treatment, the combination of erlotinib docetaxel in non-squamous NSCLC should be investigated as second line treatment. Also the question has to be answered whether the combination outperforms monotherapy treatments. After stratification for ECOG-performance status (0-1), response to prior treatment (CR, PR, SD versus PD), treatment free interval after platinum based therapy (\<6 months versus \>6 months) and maintenance, patients will be centrally randomized to receive either docetaxel (arm A) or docetaxel plus erlotinib (arm B).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed EGFR wild type, ALK negative, non-squamous cell carcinoma, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one cytotoxic treatment platinum containing regimen. Immunotherapy pretreatment is allowed
•2. Complete recovery from prior chemotherapy side effects to \< Grade 2.
•3. At least one unidimensionally measurable lesion meeting RECIST criteria.
•4. ECOG PS 0-1.
•5. Age ≥ 18 years.
•6. Adequate organ function, including:
•* Adequate bone marrow reserve: ANC \> 1.5 x 109/L, platelets ≥ 100 x 109/L.
•* Hepatic: bilirubin ≤1.5 x ULN (upper limit normal), AP, ALT, AST ≤ 1.5 x ULN. AP, ALT, and AST ≤5 x ULN is acceptable if the liver has tumor involvement.
•* Renal: calculated creatinine clearance ≥ 40 ml/min based on the Cockcroft-Gault formula.
•7. 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.
+3 more criteria

Exclusion Criteria

•1. Pregnant or lactating women.
•2. Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
•3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases at least 4 weeks before enrollment and has been off corticosteroids for at least two weeks before enrollment. Prophylactic irradiation at least 4 weeks prior to enrollment is accepted.
•4. Maintenance treatment with erlotinib or other TKI (Tyrosine Kinase Inhibitor), or docetaxel. Maintenance treatment with pemetrexed is allowed. Previous treatment with an EGFR-TKI or docetaxel within 6 months prior to enrollment.
•5. Inability or unwillingness to take dexamethasone.
•6. Concomitant treatment with any other experimental drug under investigation.
•7. Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy

Locations (19)

VUmc Medical Center

Amsterdam, North Holland, Netherlands

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Gelre Ziekenhuis

Apeldoorn, Netherlands

Amphia Hospital

Breda, Netherlands

Albert Schweitzer ziekenhuis

Dordrecht, Netherlands

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Maxima Medisch Centrum

Eindhoven, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

Spaarne Gasthuis

Hoofddorp, Netherlands

MCL

Leeuwarden, Netherlands

Key Dates

Start Date

October 14, 2016

Primary Completion Date

April 1, 2019

Completion Date

April 1, 2019

Last Updated

April 30, 2019

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-small Cell Lung

Interventions

Docetaxel

DRUG

Erlotinib

DRUG

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WITHDRAWNPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors

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