Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Dacomitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

30mg of oral dacomitinib is administered daily for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects will then continue dacomitinib at either 30mg or 45mg.

Daniel Tan, BSc, MBBS, PhD

This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IIIC/IV or recurrent EGFR-mutation-positive non-small cell lung cancer (NSCLC).

National Cancer Centre Singapore is the lead sponsor acting in a coordinating capacity and the rest of the participating sites are sponsors of their own individual sites.

Phase 2 Study of Dacomitinib in NSCLC

A Single-arm, Open-label, Phase 2 Study of Dacomitinib With or Without Dose Titration for the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Subjects With an Epidermal Growth Factor Receptor (EGFR) Activation Mutation

Percentage of subjects with PFS at 12 months

Proportion of subjects with a best overall response of either complete response (CR) or partial response (PR)

Proportion of subjects with a best overall response of either CR or PR of intracranial disease

Pfizer

National Cancer Centre, Singapore

Immunomodulating Agents

Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade

Nasal and buccal swabs, and stool sample, as well as the extracted DNAs

Microbiome

KUCC Navigation

KUCC Navigator

Jun Zhang, MD, PhD

This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.

Nasal and buccal swabs, and stool sample, as well as the extracted DNAs for current and future, study-related research

Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)

Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Treatment response will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

PD-L1 expression is per standard of care using IHC

Associate Professor; Principal Investigator

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Pemetrexed

Cisplatin

Tubulin Modulators

Antimitotic Agents

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Patients with negative driver genes advanced or metastatic NSCLC will receive sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens as first-line treatment.

Patients with non-squamous NSCLC will receive sintilimab, anlotinib hydrochloride, pemetrexed, and cisplatin or carboplatin.

Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin

Patients with squamous NSCLC will receive sintilimab, anlotinib hydrochloride, albumin paclitaxel, and carboplatin.

Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin

Lingxiang Liu, Physician

Lingxiang Liu, Dr.

This is a single-arm, prospective, exploratory clinical study aiming to evaluate the efficacy and safety profile of sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens in advanced or metastatic NSCLC as first-line treatment. Totally 40 patients with negative driver genes (20 patients of squamous cell carcinoma, 20 patients of non-squamous cell carcinoma) are to be enrolled.

Sintilimab (200 mg intravenously, once every 3 weeks; Cinda Bio-Suzhou Co., Ltd., Suzhou, Jiangsu, China) and anlotinib hydrochloride (12 mg orally, once daily before breakfast; CTTQ, Lianyungang, Jiangsu, China) are to be administered as first-line therapy in NSCLC. Besides, patients with non-squamous NSCLC will also receive pemetrexed and cisplatin or carboplatin. Meanwhile, patients with squamous NSCLC will also receive albumin paclitaxel and carboplatin. Patients assessing as CR/PR/SD will continue to receive a maintenance treatment after 4-6 cycles of treatment. Patients with non-squamous NSCLC will be treated with sintilimab + anlotinib hydrochloride + pemetrexed chemotherapy regimen while patients with squamous NSCLC will be treated with sintilimab + anlotinib hydrochloride to maintain treatment for 2 years until disease progression, intolerable toxicity, death, and patient request for discontinuation or starting new anti-tumor treatment.

Observations and assessments will be conducted before treatment, on day 7, 21 of cycle 1, on day 21 of cycle 2, every 2 cycles (42 days) during the following cycles, and after treatment. Follow-up for survival status and subsequent antineoplastic therapy data collecting will be performed by telephone interview or face-to-face every 6 weeks after treatment until disease progression, death, or end of the study (whichever occurs first).

This study will be divided into two stages: the safety lead-in period and the preliminary efficacy evaluation period. The first stage is the safety lead-in period. 3 patients with squamous NSCLC and 3 patients with non-squamous NSCLC will be enrolled to evaluate the combined therapy safety. The first 6 patients will continue to be observed from the beginning of the combined treatment until the 6th patient has been treated for 2 cycles (6 weeks). If there are less than or equal to 2 patients with intolerable side effects, they will enter the next stage. A total of 40 patients (20 patients with squamous NSCLC, 20 patients of non-squamous NSCLC) will be enrolled, and the safety and efficacy of the combined treatment will be initially evaluated. All statistics will be analyzed by statistical analysis software (SAS) 9.2 (or higher version). The single-sided 0.05 superiority hypothesis test will be used to test statistics and the comparison between groups will give a 95% confidence interval and p-value.

Efficacy is to be analyzed in the full analysis set (FAS), the response evaluable set (RES), and the per-protocol set (PPS). Safety is to be analyzed in safety set (SS) including all assigned patients who receive at least one dose of study combined therapy and have safety records of medication. Statistical descriptions of subject distribution, demographic data, and baseline characteristics will be performed. For study endpoints, the Kaplan-Meier method is to be applied for the PFS and OS curve with estimation for median PFS, median OS, and 95% CI. ORR= (CR+PR) / sample size×100%; DCR= (CR+PR+SD) / sample size×100%. The 95% CI of the ORR and DCR is to be calculated by an exact binomial method based on the F distribution. For safety analysis, only treatment-emergent adverse events (TEAE) will be included and analyzed in this experiment, which is defined as AEs that are post-dose or heavier than the baseline. Medical Dictionary for Regulatory Activities (MedDRA), system organ class (SOC), preferred terms (PT) and NCI CTCAE 5.0 will be used to standardize and classify all adverse events and summarize the incidence of AEs and association with treatments.

Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC

Sintilimab Combined With Anlotinib Hydrochloride and Standard Platinum-Containing Dual-Agent Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment: A Single-Arm, Prospective and Exploratory Clinical Study

All collected IPD and all IPD that underlie results in a publication.

Containing the incidence of complete response (CR) and partial response (PR).

From allocation to first disease progression confirmed by imaging modalities or all cause death, whichever occurs first.

Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).

The time interval from disease remission to disease progression or death (whichever occurs first).

From allocation to any cause death or last follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Study of Dacomitinib in NSCLC	NCT04027647	NSCLC Stage III... NSCLC Stage III... NSCLC Stage IV Recurrent NSCLC EGFR Positive N...	Dacomitinib	18 Years -	National Cancer Centre, Singapore
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)	NCT04636775	NSCLC Stage IV NSCLC, Recurren...	Microbiome	18 Years -	University of Kansas Medical Center
Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC	NCT04846452	Metastatic NSCL... Recurrent NSCLC Advanced Non-Sm...	Sintilimab + An... Sintilimab + An...	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University

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