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To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

ConditionNon-small Cell Lung Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAllist Pharmaceuticals, Inc.

About this trial

This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged at least 18 years.

Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.

MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.

Patients must be classified post-operatively as Stage IB, II, or IIIA on the basis of pathologic criteria.

Disqualifiers

Pre-operative or post-operative or planned radiation therapy for the current lung cancer

Pre-operative (neo-adjuvant) platinum-based or other chemotherapy

Any prior anticancer therapy

Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug: Furmonertinib 80 mg

    Drug

    The initial dose of Furmonertinib 80 mg once daily

  • Furmonertinib 80 mg placebo

    Drug

    The initial dose of Furmonertinib 80 mg once daily

Treatment groups

318 Participants
are divided into 2 treatment groups
Group A: FurmonertinibExperimental treatment 1 intervention
Group B: Placebo FurmonertinibPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

DFS

Disease free survival

Time frame
From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence). Estimated median time to event of 60 months for those treatment) [ Time Frame: Up to 5 years]

Secondary outcomes

1

Disease free survival (DFS) rate

Disease free survival (DFS) rate at 2, 3 and 5 years

Time frame
Time Frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence)Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]
2

Overall Survival (OS)

Defined as the time from the date of randomization until date of death due to any cause

Time frame
Time Frame: From date of randomization until date of death due to any cause Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]
3

Overall Survival rate at 5 years

Defined as the proportion of patients alive at 5 years, estimated from a Kaplan Meier plot of OS at the time of the primary analysis

Time frame
Time Frame: From date of randomization until date of death due to any cause about 5years[ Time Frame: Up to 5 years]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Allist Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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