A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer

• Sponsor: Dizal Pharmaceuticals (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05668988
• Collaborator: (none)
• Enrollment: 320
• Locations: 41
• Arms: 2
• Anticipated Duration (Months): 57
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage.

Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: DZD9008; Drug: Pemetrexed+carboplatin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation
• Anticipated Study Start Date: Jan 31, 2023
• Anticipated Primary Completion Date: Feb 28, 2026
• Anticipated Study Completion Date: Oct 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DZD9008	Drug: DZD9008; orally, 300 mg, once daily until a treatment discontinuation criterion is met.
Active Comparator: Platinum-based Chemotherapy	Drug: Pemetrexed+carboplatin; Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 [Up to approximately 34 months after the first participant is randomized]

Secondary Outcome Measures

1. Overall Survival [Up to approximately 34 months after the first participant is randomized]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Aged at least 18 years old (or per local regulatory/IRB requirement).

2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.

3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation

4. At least 1 measurable lesion per RECIST Version 1.1

5. Life expectancy ≥ 12 weeks

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

7. Adequate organ and hematologic function

Exclusion Criteria:

1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.

2. Spinal cord compression or leptomeningeal metastasis.

3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.

4. History of stroke or intracranial hemorrhage within 6 months before randomization.

5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing		China
2	Beijing Chest Hospital, Capital Medical University	Beijing		China
3	Cancer Hospital of the Chinese Academy of Medical Sciences	Beijing		China
4	Peking Union Medical College Hospital	Beijing		China
5	Peking University Third Hospital	Beijing		China
6	Hunan Cancer Hospital	Changsha		China
7	West China Hospital of Sichuan University	Chengdu		China
8	Army Medical Center of PLA	Chongqing		China
9	Chongqing Cancer Hospital	Chongqing		China
10	Fujian Cancer Hospital	Fuzhou		China
11	Fujian Medical University Union Hospital	Fuzhou		China
12	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou		China
13	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou		China
14	Harbin Medical University Cancer Hospital	Ha'erbin		China
15	The First Affiliated Hospital Zhejiang University School of Medicine	Hangzhou		China
16	Zhejiang Cancer Hospital	Hangzhou		China
17	Anhui Provincial Hospital	Hefei		China
18	The First Affiliated Hospital of Anhui Medical University	Hefei		China
19	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot		China
20	Jilin Cancer Hospital	Jilin		China
21	Central Hospital Affiliated to Shandong First Medical University	Jinan		China
22	Shandong Cancer Hospital & Institution	Jinan		China
23	Yunnan Cancer Hospital	Kunming		China
24	The Second Affiliated Hospital of Nanchang University	Nanchang		China
25	Jiangsu Cancer Hospital	Nanjing		China
26	Jiangsu Provincial Hospital	Nanjing		China
27	Guangxi Medical University Cancer Hospital	Nanning		China
28	Shanghai Chest Hospital	Shanghai		China
29	Shanghai Pulmonary Hospital	Shanghai		China
30	ZhongShan Hospital Fudan University	Shanghai		China
31	The First Hospital of China Medical University	Shenyang		China
32	The Fourth Hospital of Hebei Medical University	Shijiazhuang		China
33	Shanxi Provincial Cancer Hospital	Taiyuan		China
34	Taizhou Hospital of Zhejiang Province	Taizhou		China
35	Tianjin Medical University Cancer Institute & Hospital	Tianjin		China
36	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan		China
37	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan		China
38	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an		China
39	Yantai Yuhuangding Hospital	Yantai		China
40	Henan Cancer Hospital	Zhengzhou		China
41	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China

Sponsors and Collaborators

• Dizal Pharmaceuticals

Investigators

• Principal Investigator: Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dizal Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05668988
• Other Study ID Numbers: DZ2022E0005
• First Posted: Dec 30, 2022
• Last Update Posted: Dec 30, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carboplatin; Pemetrexed

Study Results

No Results Posted as of Dec 30, 2022