Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alectnib · 1 trial · 1 indication
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
| Arm | Type | Description |
|---|---|---|
| Alectinib | EXPERIMENTAL | - |
| Platinum-Based Chemotherapy | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Alectnib | DRUG | Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first. |
| Cisplatin | DRUG | Participants will receive Cisplatin 75 milligrams per square meter (mg/m\^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first." |
| Vinorelbine | DRUG | Participants will receive Vinorelbine 25 mg/m\^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. |
| Gemcitabine | DRUG | Participants will receive Gemcitabine 1250 mg/m\^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. |
| Pemetrexed | DRUG | Participants will receive 500 mg/m\^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first." |
| Carboplatin | DRUG | For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used. |
Key Inclusion Criteria * Age ≥18 years * Complete resection of histologically confirmed Stage IB (tumor ≥ 4 cm) to Stage IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le Cancer / American Joint Committee on Cancer, 7th edition, with negative margins, at 4-12 wee...
Alectinib is an investigational small molecule being studied for the treatment of non-small-cell lung cancer (NSCLC). It is currently in Phase 3 clinical development as an adjuvant therapy, meaning it is given after surgery to help prevent the cancer from returning. The drug is being evaluated in patients with ALK-positive NSCLC.
Alectinib targets anaplastic lymphoma kinase (ALK), a protein that can drive cancer growth when mutated or rearranged. By inhibiting ALK, the drug aims to block signals that promote tumor cell proliferation. This makes it a targeted therapy for patients whose tumors harbor ALK alterations, which are common in certain subtypes of non-small-cell lung cancer.
Alectinib is developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with non-small-cell lung cancer. The company is responsible for the drug's development and regulatory strategy.
Alectinib is currently in Phase 3 clinical development. It is being studied in an active, not recruiting trial that compares adjuvant alectinib versus adjuvant platinum-based chemotherapy in patients with ALK-positive non-small-cell lung cancer. The drug is investigational and has not yet been approved by regulatory authorities.
Alectinib is being evaluated in a Phase 3 clinical trial with the identifier NCT03456076. This study compares adjuvant alectinib versus adjuvant platinum-based chemotherapy in patients with ALK-positive non-small-cell lung cancer. The trial is active but not recruiting, with an enrollment of 257 participants across multiple countries.
Alectinib is the same drug as Alecensa, which is a brand name used by Roche. The active ingredient is alectinib, and it is being studied for the treatment of non-small-cell lung cancer. The drug is currently in Phase 3 clinical trials and has not yet been approved.