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MEGF0444A

Phase 2

Non-Squamous Non-Small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Dec 12, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

MEGF0444A · 3 trials · 2 indications

Phase 2 1Phase 1 2
NCT01366131Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin, Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease (NILE)Non-Squamous Non-Small Cell Lung Cancer
COMPLETED104 Analytics
PHASE2COMPLETED
Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin, Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease (NILE)
Non-Squamous Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
Up to 24 months
Incidence and nature of dose-limiting toxicities (DLTs)
Days 1 to 28 of Cycle 1
Incidence, nature, and severity of adverse events
Until 90 days after last dose of study treatment
Incidence, nature, relatedness, and severity of adverse events
Day 1 to study completion

Secondary Endpoints

Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
Up to 24 months
Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study)
Up to 24 months
Overall survival (defined as the time from randomization until death from any cause)
Up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
1EXPERIMENTAL -

Interventions

NameTypeDescription
MEGF0444ADRUGIntravenous repeating dose
bevacizumabDRUGIntravenous repeating dose
carboplatinDRUGIntravenous repeating dose
paclitaxelDRUGIntravenous repeating dose
placeboDRUGIntravenous repeating dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Histologically or cytologically documented inoperable (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC that are based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predom...

Countries:United StatesAustraliaCzechiaFranceGermanyHungaryPoland
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Frequently asked questions about MEGF0444A

What is MEGF0444A used for?

MEGF0444A is an investigational oncology drug being studied for non-squamous non-small cell lung cancer and solid cancers. It is being developed by Roche Holding AG (RHHBY) and is currently in Phase 2 clinical development.

What does MEGF0444A target?

MEGF0444A is a small molecule being studied in oncology. Its specific molecular target has not been disclosed in available clinical trial information.

Who makes MEGF0444A?

MEGF0444A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 2 clinical trials for oncology indications.

What phase is MEGF0444A in?

MEGF0444A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.

What clinical trials is MEGF0444A in?

MEGF0444A has been studied in three completed clinical trials. NCT01366131 is a Phase 2 trial in non-squamous non-small cell lung cancer. NCT00909740 and NCT01075464 are Phase 1 trials in solid cancers, with the latter combining MEGF0444A with bevacizumab and paclitaxel.

Is MEGF0444A the same as any other drug?

MEGF0444A is also known by the name NILE in the context of a clinical trial. The Phase 2 study NCT01366131 is referred to as the NILE study, evaluating MEGF0444A in combination with carboplatin, paclitaxel, and bevacizumab.