Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lomustine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| First-Line Bevacizumab followed by Bevacizumab + Lomustine/SOC | EXPERIMENTAL | Participants will receive first-line treatment with radiotherapy, temozolomide, and bevacizumab. All three treatments will be given concurrently for the first 6 weeks, followed by 6 cycles (28 days each) of temozolomide plus bevacizumab, followed by bevacizumab monotherapy until PD1 or unacceptable toxicity. At PD1, participants randomized to bevacizumab will receive bevacizumab plus lomustine until PD2. Following PD2, participants will continue with blinded bevacizumab with the addition of appropriate SOC. Following PD3, for subsequent treatment lines blinded bevacizumab may continue or open-label bevacizumab may be given at the discretion of the investigator and the participant. |
| First-Line Bevacizumab followed by Placebo + Lomustine/SOC | PLACEBO_COMPARATOR | Participants will receive first-line treatment with radiotherapy, temozolomide, and bevacizumab. All three treatments will be given concurrently for the first 6 weeks, followed by 6 cycles (28 days each) of temozolomide plus bevacizumab, followed by bevacizumab monotherapy until PD1 or unacceptable toxicity. At PD1, participants randomized to placebo will receive placebo plus lomustine until PD2. Following PD2, participants will continue with blinded placebo with the addition of appropriate SOC. Following PD3, for subsequent treatment lines blinded bevacizumab may continue or open-label bevacizumab may be given at the discretion of the investigator and the participant. |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | Bevacizumab will be administered at a dose of 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks (Q2W) throughout the study, with the exception of bevacizumab monotherapy prior to PD1, which will be given as 15 mg/kg IV every 3 weeks (Q3W). |
| Lomustine | DRUG | Lomustine will be administered at a dose of 90 milligrams per square meter (mg/m\^2) orally (PO) every 6 weeks (Q6W), with a cap of 160 milligrams (mg) per dose. In the absence of hematologic toxicity following the first dose, the second and subsequent doses may be increased to 110 mg/m\^2 PO Q6W, with a cap of 200 mg per dose. |
| Placebo | DRUG | Placebo will be administered via IV infusion, in a formulation matched to bevacizumab, Q2W after randomization. |
| Radiotherapy | RADIATION | Radiotherapy will be administered for a total dose of 60 Gray (Gy), administered in 2-Gy fractions, 5 days per week for 6 weeks during first-line treatment. |
| Temozolomide | DRUG | Temozolomide will be administered orally (PO) as 75 mg/m\^2 per day for the first 6 weeks of first-line treatment (concurrent treatment), followed by 6 cycles (28 days each) as follows: 150 mg/m\^2 per day for the first 5 days of Cycle 1, then 200 mg/m\^2 per day (if permitted by the participant's hematological and non-hematological toxicity profile) for the first 5 days of Cycles 2-6. |
| SOC Agent | DRUG | The choice of SOC agent will be at the discretion of investigator. The SOC agent will be administered during third-line treatment and subsequent lines, as per standard practice. |
Inclusion Criteria at Enrollment (before PD1): * Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherapy or radiotherapy * If female and not postmenopausal (less than \[\<\] 12 months of amenorrhea) or surgically sterile, must agree to use a highly effective ...
Lomustine is an investigational small molecule being studied for the treatment of glioblastoma, a type of brain cancer. It is currently in Phase 2 clinical development. Lomustine is being evaluated in combination with other therapies to assess its potential benefit for patients with this condition.
Lomustine is being developed by Roche Holding AG, a biopharmaceutical company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glioblastoma. The company is responsible for the ongoing research and development of this investigational therapy.
Lomustine is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a clinical trial to evaluate its effects in patients with glioblastoma, and its safety and efficacy have not been fully established.
Lomustine has been studied in a completed Phase 2 clinical trial with the identifier NCT01860638. This trial enrolled 296 participants with glioblastoma and compared continuous bevacizumab treatment or placebo in addition to lomustine, followed by standard of care after disease progression. The trial was randomized, double-blind, and placebo-controlled.
Lomustine is a small molecule that works by targeting and interfering with the growth of cancer cells. It is being studied for its potential to treat glioblastoma, a type of brain tumor. The drug's mechanism of action is designed to disrupt the replication of cancer cells, which may help slow or stop tumor growth.