AzTrials
AzTrials

Carcinoma, Non-Small Cell LungPhase 3NCT02743923

Cisplatin-Pemetrexed Compared With Carboplatin-Paclitaxel-Bevacizumab in KRAS Mutated Non-small Cell Lung Cancer

A Phase 3 study testing carboplatin, paclitaxel and Bevacizumab in people with Carcinoma, Non-Small Cell Lung, run by The Netherlands Cancer Institute at 28 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results in a prolonged progression free survival compared to cisplatin-pemetrexed as first line treatment in patients with KRAS mutated non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small Cell Lung
What is being tested?
carboplatin, paclitaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
28 sitesNetherlands
Study dates
Apr 2016to Apr 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed (non-squamous) NSCLC incurable locally advanced or metastatic (stage IIIB and stage IV) disease.
  • Documented KRAS mutation
  • 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.
  • At least one unidimensionally measurable lesion meeting RECIST1.1.
  • ECOG PS 0-2
  • Age ≥ 18 years
Show all 13Show fewer
  • 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.
  • Signed informed consent
  • 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.

Who cannot join

  • Pregnant or lactating women
  • 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)
  • History of hemoptysis ≥ grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
  • Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery)
  • Patients with evidence or history of bleeding diathesis
  • Non-healing wound or ulcer

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Netherlands28 sites

  • Jeroen Bosch Hospital

    's-Hertogenbosch

  • ZGT

    Almelo, 7609 PP

  • Meander Medical Center

    Amersfoort, Utrecht, 3818 ES

  • VUmc Medical Center

    Amsterdam, North Holland, 1081HV

  • Antoni van Leeuwenhoek

    Amsterdam, 1066CX

  • OLVG

    Amsterdam, 1090 HM

  • Gelre Ziekenhuis

    Apeldoorn

  • Amphia Hospital

    Breda

  • Deventer Ziekenhuis

    Deventer

  • Albert Schweitzer ziekenhuis

    Dordrecht

  • Ziekenhuis Gelderse Vallei

    Ede

  • Maxima Medisch Centrum

    Eindhoven, 5631 BM

  • Medical spectrum Twente

    Enschede, Overijssel, 7500 KA

  • Groene Hart

    Gouda

  • UMCG

    Groningen, 9713 GZ

  • Martini Ziekenhuis

    Groningen

  • Tergooi ziekenhuizen

    Hilversum

  • Spaarne Gasthuis

    Hoofddorp, 2130 AT

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Maastricht University Medical Center

    Maastricht

  • Maasstad ziekenhuis

    Rotterdam, 3007 AC

  • St. Fransicus Gasthuis

    Rotterdam, 3045 PM

  • Haga

    The Hague, 2545 CH

  • Medical Center Haaglanden

    The Hague

  • Diakonessenhuis Utrecht

    Utrecht, 3582 KE

  • St. Antonius ziekenhuis

    Utrecht

  • VieCuri Medisch Centrum voor Noord-Limburg

    Venlo

  • Isala Klinieken

    Zwolle, 8000 GK

Other trials in Netherlands

About this study

Official title: 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

The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results in a prolonged progression free survival compared to cisplatin-pemetrexed as first line treatment in patients with KRAS mutated non-small cell lung cancer.

Read the detailed description

KRAS mutations occur in 30% of patients with non-small cell lung cancer, especially adenocarcinoma. For long time KRAS mutation has been related with poor prognosis and poor response to chemotherapy. Recent data however show that this is both not true. It seems that response, progression free survival and overall survival is similar in KRAS mutated. Until now no specific targeted therapy is available for KRAS mutated NSCLC patients. Optimization of treatment in advanced NSCLC patients with a KRAS mutation could also be achieved by selecting the best available chemotherapy treatment.

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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02743923
Study groupRoleWhat they receive
carboplatin-paclitaxel- bevacizumabActive comparatorcarboplatin 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
Receives: Drug: carboplatin; Drug: paclitaxel; Drug: Bevacizumab
cisplatin-pemetrexedActive comparatorpemetrexed 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.
Receives: Drug: Pemetrexed; Drug: cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    Measured: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months

Secondary outcomes (4)

  1. disease control rate

    Measured: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months.

  2. overall survival

    Stratification for KRAS mutation (G12V versus G12C versus other)

    Measured: date of randomization to the date of death from any cause, assessed up to 60 months.

  3. outcome between G12V versus G12C versus other subtypes of KRAS mutations (mutational analysis on plasma and blood platelets).

    The two most common KRAS types are G12C in about 40% of cases, G12V in 18% and G12D in 15% of cases. Subgroup analyses are planned to explore treatment effect in these different KRAS mutations groups. At baseline the metastatic patterns of these subgroups will be described. KRAS mutations in NSCLC occur mainly in codon 12 and 13.

    Stratification for KRAS mutation (G12V versus G12C versus other) at randomization.

    Measured: date of randomization to the date of death from any cause, assessed up to 60 months.

  4. response by Crabb criteria (if applicable)

    Measured: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion19 Sep 2021
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02743923
Sponsor's protocol ID
NVALT 22
Status last verified
Dec 2021
First submitted
17 Mar 2016
Last updated
21 Dec 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, paclitaxel and Bevacizumab in people with Carcinoma, Non-Small Cell Lung, run by The Netherlands Cancer Institute at 28 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02743923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in