2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC) (NVALT10)
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ClinicalTrials.gov Identifier: NCT00835471 |
Recruitment Status :
Completed
First Posted : February 3, 2009
Last Update Posted : September 29, 2020
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small-Cell Lung | Drug: erlotinib plus docetaxel or pemetrexed Drug: erlotinib | Phase 2 |
Open randomized multicenter phase II study in patients in need of 2nd line treatment for advanced/metastatic NSCLC. Efficacy and safety of monotherapy with erlotinib will be compared with combination therapy of erlotinib and chemotherapy. In recent studies it was established that pemetrexed activity is more pronounced in non-squamous NSCLC in comparison to squamous cell carcinoma. Therefore in patients with non-squamous carcinoma pemetrexed will be used. As in second line treatment of NSCLC docetaxel is registered also for usage in patients with squamous cell carcinoma, docetaxel will be used in patients with squamous histology.
Chemotherapy will be limited to 4 courses. Erlotinib will be continued until disease progression or unacceptable toxicity.
Erlotinib as monotherapy will be administered continuously. In combination with chemotherapy, erlotinib will be given from day 2-16 of every course of 3 weeks.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 195 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study) |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
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Experimental: 1
Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
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Drug: erlotinib plus docetaxel or pemetrexed
non-squamous carcinoma: pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16, every 21 days. Pemetrexed will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression. squamous carcinoma: Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days. Docetaxel will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression. Other Names:
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Active Comparator: 2
Erlotinib
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Drug: erlotinib
erlotinib 150 mg/day continuously until disease progression
Other Name: Tarceva |
- Progression Free Survival (PFS) [ Time Frame: From randomisation to date of first progression or date of death, assessed up to 36 months ]to compare the PFS in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent Progression free survival
- Number of Adverse Events [ Time Frame: From randomisation to 30 days after EoT all AEs are collected ]to compare relevant toxicity (CTC AE vs 3.0) in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed NSCLC, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
- Complete recovery from prior chemotherapy side effects to < Grade 2.
- At least one unidimensional measurable lesion meeting RECIST criteria.
- ECOG PS 0-2.
- Age > 18 years.
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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, AP, ALT, AST < 1.5 x ULN AP, ALT, and AST <5 x ULN is acceptable if the liver has tumor involvement
- Renal: calculated creatinin clearance > 40 ml/min based on the Cockcroft-Gault formula.
- Estimated life expectancy >12 weeks.
- 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.
- Signed informed consent.
- Patient compliance and geographical proximity that allow adequate follow up.
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
- Documented 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.
- Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
- Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
- Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
- Concomitant treatment with any other experimental drug under investigation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835471
Netherlands | |
VU medisch centrum | |
Amsterdam, Netherlands | |
Rode Kruis Ziekenhuis | |
Beverwijk, Netherlands | |
Amphia Ziekenhuis | |
Breda, Netherlands | |
Reinier de Graaf Gasthuis | |
Delft, Netherlands | |
Jeroen Bosch Ziekenhuis | |
Den Bosch, Netherlands | |
Catharina-Ziekenhuis | |
Eindhoven, Netherlands | |
Martini Ziekenhuis | |
Groningen, Netherlands | |
Kennemer Gasthuis | |
Haarlem, Netherlands | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands | |
Universitair Medisch Centrum Sint Radboud | |
Nijmegen, Netherlands | |
Maasstad Ziekenhuis | |
Rotterdam, Netherlands | |
Sint Franciscus Gasthuis | |
Rotterdam, Netherlands | |
HagaZiekenhuis | |
The Hague, Netherlands | |
Isala Klinieken | |
Zwolle, Netherlands |
Study Director: | Joachim G. Aerts, MD PhD | Amphia Ziekenhuis, Breda, The Netherlands | |
Study Director: | Henk E. Coderington, MD | HagaZiekenhuis, The Hague, The Netherlands |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dutch Society of Physicians for Pulmonology and Tuberculosis |
ClinicalTrials.gov Identifier: | NCT00835471 |
Other Study ID Numbers: |
NVALT10 |
First Posted: | February 3, 2009 Key Record Dates |
Last Update Posted: | September 29, 2020 |
Last Verified: | September 2020 |
Lung cancer non-small-cell erlotinib chemotherapy |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel |
Pemetrexed Erlotinib Hydrochloride Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |