Cisplatin-Pemetrexed Compared With Carboplatin-Paclitaxel-Bevacizumab in KRAS Mutated Non-small Cell Lung Cancer
NCT ID: NCT02743923
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
203 participants
INTERVENTIONAL
2016-04-30
2024-04-30
Brief Summary
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Detailed Description
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Two standard chemotherapy schemes are frequently used and FDA and EMA approved as first line treatment for patients with adenocarcinoma: cisplatin-pemetrexed and carboplatin-paclitaxel-bevacizumab.
The aim of this randomized phase III study is to compare two standard treatment regimens in patients with KRAS mutated, advanced stage NSCLC and the hypothesis is that bevacizumab with chemotherapy improves outcomes compared to chemotherapy alone as first line treatment. Furthermore the outcome for the different KRAS mutations will be studied.
Treatment with one of the two following chemotherapy combinations according to the label: carboplatin-paclitaxel-bevacizumab or cisplatin-pemetrexed q3wks for up to six cycles. Continuation maintenance with bevacizumab and pemetrexed is allowed until progression. Blood and archival tissue will be optionally collected for translational research. This may help to identify subgroups of patients who are likely better treated with a specific treatment regimen.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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carboplatin-paclitaxel- bevacizumab
carboplatin AUC 6, paclitaxel 200 mg/m2, bevacizumab 15 mg/kg all administered intravenously on day 1 every 3 weeks for 4-6 cycles, followed by bevacizumab maintenance every 3 weeks until progression
carboplatin
AUC 6
paclitaxel
200mg/m2
Bevacizumab
15 mg/kg
cisplatin-pemetrexed
pemetrexed 500 mg/m2 administered intravenously on day 1 and cisplatin 75 mg/m2 administered intravenously on day 1 every 3 weeks for 4-6 cycles, followed by maintenance pemetrexed every 3 weeks until progression.
Pemetrexed
500 mg/m2
cisplatin
75 mg/m2
Interventions
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carboplatin
AUC 6
paclitaxel
200mg/m2
Bevacizumab
15 mg/kg
Pemetrexed
500 mg/m2
cisplatin
75 mg/m2
Eligibility Criteria
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Inclusion Criteria
2. Documented KRAS mutation
3. Chemotherapy-naive NSCLC patients. Adjuvant chemotherapy or chemoradiotherapy is allowed when given \> 1 year for study entry. Previous anti-PD(L1) therapy for advanced disease is allowed.
4. At least one unidimensionally measurable lesion meeting RECIST1.1.
5. ECOG PS 0-2
6. Age ≥ 18 years
7. 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 ≤ 3.0 x ULN AP, ALT, and AST ≤5 xULN is acceptable if the liver has tumor involvement
* Renal: calculated creatinine clearance ≥ 60 ml/min based on the Cockroft-Gault formula.
* Urine protein (dip-stick) \< 2 +; when ≥ 2 +: 24 hours urine protein ≤ 1 gr.
8. Signed informed consent
9. 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.
Exclusion Criteria
2. Clinically significant (i.e. active) cardiovascular disease: congestive heart failure \>NYHA class 2; CVA or myocardial infarction \< 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic \> 150 mmHg and/or diastolic \> 100 mmHg)
3. History of hemoptysis ≥ grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
4. Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery)
5. Patients with evidence or history of bleeding diathesis
6. Non-healing wound or ulcer
18 Years
ALL
No
Sponsors
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Dutch Society of Physicians for Pulmonology and Tuberculosis
OTHER
The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Anne-Marie C Dingemans, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dutch Society of Physicians for Pulmonology and Tuberculosis
Locations
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VUmc Medical Center
Amsterdam, North Holland, Netherlands
Medical spectrum Twente
Enschede, Overijssel, Netherlands
Meander Medical Center
Amersfoort, Utrecht, Netherlands
Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
ZGT
Almelo, , Netherlands
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
OLVG
Amsterdam, , Netherlands
Gelre Ziekenhuis
Apeldoorn, , Netherlands
Amphia Hospital
Breda, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
Groene Hart
Gouda, , Netherlands
UMCG
Groningen, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Tergooi ziekenhuizen
Hilversum, , Netherlands
Spaarne Gasthuis
Hoofddorp, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Maasstad ziekenhuis
Rotterdam, , Netherlands
St. Fransicus Gasthuis
Rotterdam, , Netherlands
Haga
The Hague, , Netherlands
Medical Center Haaglanden
The Hague, , Netherlands
Diakonessenhuis Utrecht
Utrecht, , Netherlands
St. Antonius ziekenhuis
Utrecht, , Netherlands
VieCuri Medisch Centrum voor Noord-Limburg
Venlo, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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Other Identifiers
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NVALT 22
Identifier Type: -
Identifier Source: org_study_id