Research with human participants

Overview of medical research in the Netherlands

Chemotherapy in KRAS mutated chemotherapy naive non-small cell lung cancer patients: a phase III study comparing cisplatin-pemetrexed with carboplatin-paclitaxel-bevacizumab: NVALT 22

Published:
Last updated:

To compare two (standard) treatment regimens in patients with KRAS mutated advanced stage NSCLC as first line treatment.

Download: PDF | XML
Ethical review
Approved WMO
Status
Recruiting
Health condition type
Respiratory and mediastinal neoplasms malignant and unspecified
Study type
Interventional

ID

NL-OMON55867

Source

ToetsingOnline

Brief title

NVALT 22

Condition

  • Respiratory and mediastinal neoplasms malignant and unspecified

Synonym

Non-small cell lung cancer; KRAS mutation

Research involving

Human

Sponsors and support

Primary sponsor :
Stichting NVALT studies
Source(s) of monetary or material Support :
Eli Lilly,Roche,stichting NVALT (non-profit)

Intervention

Keyword :
KRAS mutation, NSCLC, Phase III

Outcome measures

Primary outcome

To investigate in KRAS mutated patients with incurable NSCLC whether

carboplatin-paclitaxel-bevacizumab results in a prolonged progression free

survival compared to cisplatin-pemetrexed as first line treatment.

Secondary outcome

- To investigate differences in overall response rate (ORR) and disease control

rate

- To investigate differences in overall survival

- To investigate differences in outcome between different subtypes of KRAS

mutations

- To investigate response by Crabb criteria

Background summary

In a retrospective analysis of KRAS mutated non-small cell lung cancer (NSCLC)
patients response and progression free survival to first line chemotherapy was
better for carboplatin-paclitaxel-bevacizumab then other first line
combinations.

Study objective

To compare two (standard) treatment regimens in patients with KRAS mutated
advanced stage NSCLC as first line treatment.

Study design

A multicenter, randomized, open-label, phase III study in patients with KRAS
mutated NSCLC receiving first line treatment. Patients will be randomized 1:1
to a standard and approved first line chemotherapy. Arm A: 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.
Arm B: pemetrexed 500 mg/m2, cisplatin 75 mg/m2 all administered intravenously
on day 1 every 3 weeks for 4-6 cycles, followed by maintenance pemetrexed every
3 weeks until progression.

Intervention

Blood and archival tissue will be optionally collected (after consent of the
patient) for translational research.

Study burden and risks

Both arms are standard of care first line treatments; no extra burden or risk
for the patient.

Public
Stichting NVALT studies

Luijbenstraat 15
's-Hertogenbosch 5211BR
NL
Scientific
Stichting NVALT studies

Luijbenstraat 15
's-Hertogenbosch 5211BR
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)

Inclusion criteria

Histologically or cytologically confirmed NSCLC (Stage IIIB or IV)
Documented KRAS mutation
Chemotherapy-naive NSCLC patients
ECOG PS 0-2
Age 18 years or older
Adequate bone marrow, hepatic and renal function

Exclusion criteria

Pregnant or lactating women
Active cardiovascular disease
History of hemoptysis greater or equal to grade 2
Evidence of tumor invading major blood vessels on imaging

Design

Study phase :
3
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
240
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Alimta
Generic name :
pemetrexed
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
Avastin
Generic name :
bevacizumab
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
carboplatin
Generic name :
carboplatin
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
cisplatin
Generic name :
cisplatin
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
Taxol
Generic name :
paclitaxel
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
First submission
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
PTC Stichting het Nederlands Kanker Instituut - Antoni van Leeuwenhoekziekenhuis (Amsterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2015-003121-34-NL
ClinicalTrials.gov NCT02743923
CCMO NL52808.031.15