Carcinoma, Non-small Cell LungPhase 3NCT02775006
Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma
A Phase 3 study testing Docetaxel and Erlotinib in people with Carcinoma, Non-small Cell Lung, run by The Netherlands Cancer Institute at 19 sites in Netherlands.
Trial 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. 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?
- Docetaxel and Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 19 sitesNetherlands
- Study dates
- 14 Oct 2016to Apr 2019
- 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 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
- Complete recovery from prior chemotherapy side effects to < Grade 2.
- At least one unidimensionally measurable lesion meeting RECIST criteria.
- ECOG PS 0-1.
- Age ≥ 18 years.
- Adequate organ function, including:
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- 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.
- 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.
- Patients who have undergone cranial irradiation for brain metastases more than 4 weeks before inclusion in our protocol, provided that they are clinically fit to undergo second line treatment
Who cannot join
- 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 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.
- 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.
- Inability or unwillingness to take dexamethasone.
- Concomitant treatment with any other experimental drug under investigation.
- Patients experiencing disease progression within 2 months after the start of platinum based chemotherapy
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Netherlands19 sites
Jeroen Bosch Hospital
's-Hertogenbosch
VUmc Medical Center
Amsterdam, North Holland, 1081HV
Gelre Ziekenhuis
Apeldoorn
Amphia Hospital
Breda
Albert Schweitzer ziekenhuis
Dordrecht
Ziekenhuis Gelderse Vallei
Ede
Maxima Medisch Centrum
Eindhoven, 5631 BM
Martini Ziekenhuis
Groningen
Spaarne Gasthuis
Hoofddorp, 2130 AT
MCL
Leeuwarden, 8934 AD
Maastricht University Medical Center
Maastricht
Laurentius Hospital
Roermond
St. Fransicus Gasthuis
Rotterdam, 3045 PM
Ikazia
Rotterdam, 3083 AN
Erasmus MC
Rotterdam
Haga
The Hague, 2545 CH
Medical Center Haaglanden
The Hague
St. Antonius ziekenhuis
Utrecht
VieCuri Medisch Centrum voor Noord-Limburg
Venlo
About this study
Official title: 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)
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.
Read the 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).
- Conditions
- Carcinoma, Non-small Cell Lung
- 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 group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | Docetaxel 75mg/m2 every 21 days until disease progression or toxicity related Receives: Drug: Docetaxel |
| Docetaxel plus erlotinib | Active comparator | Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related. Receives: Drug: Docetaxel; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
Secondary outcomes (4)
quantitative and qualitative adverse events
Adverse events will be graded according to NCI Common Toxicity Criteria version 4.03
Measured: from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
response rates
Measured: Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
duration of response
Measured: from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
overall survival
Evaluation of overall survival (OS)
Measured: from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start14 Oct 2016
- Primary completionApr 2019
- Study completionApr 2019
Why it stopped: accrual to slow, target not achievable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-small Cell LungStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Society of Physicians for Pulmonology and Tuberculosis
- Responsible party
- Sponsor
- Investigators
- Joachim G Aerts, MD PhD, Principal investigator, Dutch Society of Physicians for Pulmonology and Tuberculosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775006
- Sponsor's protocol ID
- NVALT 18
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2016
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02775006
- Acronym / sponsor ID
- NVALT 18
- Conditions
- Carcinoma, Non-small Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: accrual to slow, target not achievable
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Dutch Society of Physicians for Pulmonology and Tuberculosis
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: DocetaxelDocetaxel 75mg/m2 every 21 days until disease progression or toxicity related |
| Docetaxel plus erlotinib | Active comparator | Drug: Docetaxel, Drug: ErlotinibDocetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days, until disease progression, or toxicity related. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Complete recovery from prior chemotherapy side effects to < Grade 2.
- At least one unidimensionally measurable lesion meeting RECIST criteria.
- ECOG PS 0-1.
- Age ≥ 18 years.
Key exclusion criteria (7 listed)
- 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 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.
- 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.
- Inability or unwillingness to take dexamethasone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere75mg/m2 | Drug | Docetaxel, Docetaxel plus erlotinib |
| ErlotinibAlso: Tarceva150mg/day | Drug | Docetaxel plus erlotinib |
Primary outcome
progression free survival
Time frame: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration
4 secondary outcomes
quantitative and qualitative adverse events
Time frame: from the date of randomization until resolution or stabilization of the event and up to 30 days after the last study medication/treatment
response rates
Time frame: Every six weeks from date of randomization until the date of first documented progression or date of death from any cause up to 24 months after last treatment administration
duration of response
Time frame: from the date of the first objective status assessment of a complete or partial response to the first date of progression of disease or death from any cause up to 24 months after last treatment administration
overall survival
Time frame: from the date of randomization to the date of death from any cause up to 24 months after last treatment administration
Results and safety
The study was stopped early (reason given: accrual to slow, target not achievable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim G Aerts, MD PhD principal investigator
Dutch Society of Physicians for Pulmonology and Tuberculosis
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel and Erlotinib in people with Carcinoma, Non-small Cell Lung, run by The Netherlands Cancer Institute at 19 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 7 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: stopped early, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
The study was stopped early (reason given: accrual to slow, target not achievable). 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: from the date of randomization to the first date of progression of disease or of death from any cause up to 24 months after last treatment administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2019.