ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer (ALERT-lung)
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|ClinicalTrials.gov Identifier: NCT03445000|
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Recurrent||Drug: Alectinib||Phase 2|
The trial is investigating the efficacy of alectinib in patients with advanced stage RET-rearranged NSCLC, treated with at least one platinum based systemic chemotherapy regimen. Preclinical studies have shown that alectinib, a highly selective next generation ALK inhibitor, has potent anti-tumour activity in RET-rearranged NSCLC. Therapeutically, several multiple kinases inhibitors, are potentially able to inhibit RET kinase function, which has been tested in several unselected NCSLC trials. However, those result were negative and none of the tested drugs was approved for lung cancer treatment.
The ALERT-lung trial is a single arm, phase II trial with the primary objective to assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1 in selected NSCLC patients with RET rearrangement. The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free survival (PFS), and overall survival (OS) as well as to assess safety and tolerability of the treatment and to describe the association of primary and secondary outcomes with tumour characteristics.
Alectinib is administered orally, 600 mg, twice per day, until progression, refusal or unacceptable toxicity. Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit. A total sample size of 44 patients is required.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Trial Evaluating the Activity of Alectinib for the Treatment of Pretreated RET-rearranged Advanced NSCLC|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Trial treatment
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
Other Name: Alecensa
- Best overall response [ Time Frame: From the start of trial treatment across all time points until the end of trial treatment, assssed up to 44 months. ]Best overall response (OR = CR or PR), per investigator assessment according to RECIST 1.1.
- Best overall response per independent review [ Time Frame: From the start of trial treatment across all time points until the end of trial treatment, assssed up to 44 months. ]Best overall response (OR = CR or PR), per independent review assessment according to RECIST 1.1.
- Disease control at 24-weeks [ Time Frame: 24 weeks after treatment start ]Best overall response of CR or PR, or SD (or non-CR/non-PD in the case of non-measurable disease only)
- Progression-free survival (PFS) [ Time Frame: From date of enrolment until date of documented progression or death, if progression is not documented, assessed up to 44 months. ]PFS will be assessed according to RECIST 1.1 criteria.
- Overall survival (OS) [ Time Frame: From date of enrolment until date of death from any cause, assessed up to 44 months. ]Defined as the time from date of enrollment until death from any cause.
- Safety and tolerability of alectinib treatment [ Time Frame: Assessed from date of signature of informed consent until 30 days after treatment is ceased for any reason. ]The safety and tolerability of alectinib treatment will be assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
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): NCT03445000
|Contact: Barbara Ruepp, PharmDfirstname.lastname@example.org|
|Study Chair:||Enriqueta Felip, MD-PhD||Vall d'Hebron University Hospital|
|Study Chair:||Jürgen Wolf, MD-PhD||University Hospital Cologne|
|Study Chair:||Egbert F. Smith, MD-PhD||The Netherlands Cancer Institute Amsterdam|