NSCLC Stage IIIBPhase 2NCT04027647
Phase 2 Study of Dacomitinib in NSCLC
A Phase 2 study testing Dacomitinib in people with NSCLC Stage IIIB and NSCLC Stage IIIC, run by National Cancer Centre, Singapore at 9 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IIIB, NSCLC Stage IIIC, NSCLC Stage IV
- What is being tested?
- Dacomitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 11 Sep 2019to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of a voluntarily given, personally signed and dated, written informed consent document;
- Male or female adult as defined by local regulation;
- The presence of an EGFR activating mutation (exon 19 deletion or the L858R mutation in exon 21) in tumor specimen determined by the local laboratory;
- Evidence of newly diagnosed stage IIIB/IIIC/IV (based on Union for International Cancer Control (UICC) staging system version 8) or recurrent (minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC required) NSCLC of adenocarcinoma histo- and/or cytopathology or its pathologically accepted variants using tumor specimen (assessed according to accepted standards by a local laboratory). For this purpose the World Health Organization/International Association of Study of Lung Cancer Histologic Classification of Lung Cancer Criteria will be used and the diagnosis of NSCLC NOS (not otherwise specified), squamous or mixed adeno-squamous lung carcinomas will not be allowed;
- Have an ECOG PS of 0 or 1;
- No prior treatment with systemic therapy for locally advanced or metastatic NSCLC. Completed neoadjuvant/adjuvant chemotherapy/immunotherapy and/or combined modality chemotherapy/radiation therapy permitted only in cases in which there is a minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC. Prior treatment with a EGFR-TKI or other TKIs is not allowed;
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- Radiologically measurable disease by RECIST v1.1 criteria:
- At least one target lesion that has not previously been radiated, and is measurable according to RECIST v1.1;
- Acceptable radiologic procedures for disease assessment include contrast enhanced conventional or spiral computed tomography (CT), or contrast enhanced magnetic resonance imaging (MRI); Non-contrast CT scan is acceptable only for subjects who are both allergic to intravenous contrast and unable to cooperate with MRI, or MRI is not available. The following are not allowed as sole documentation of target lesions: CT component of positron emission tomography (PET)/CT, ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or bone radiographs, and tumor markers;
- Adequate organ function, including:
- Estimated creatinine clearance ≥30 mL/min (as determined by Cockcroft-Gault formula or the study site's standard formula);
- Absolute neutrophil count (ANC) ≥1500 cells/mm3;
- Platelets ≥100,000 cells/mm3;
- Hemoglobin ≥10.0 g/dL;
- Bilirubin ≤1.5 x ULN;
- AST (also known as SGOT) and ALT (also known as SGPT) ≤2.5 x ULN (≤5.0 x ULN if hepatic metastases).
- Female subjects must be postmenopausal (defined as 12 months of amenorrhea following last menses), or they or their partners must be surgically sterile, or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the investigator using following criteria:
- Acceptable contraception for women include implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been surgically sterile (e.g. by vasectomy) for at least 6 months. Acceptable contraception for a male includes surgical sterility (e.g. by vasectomy) for at least 6 months, sexual abstinence, or condoms plus spermicide.
- All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to starting study treatment;
- Male subjects or their female partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the investigator. Or female partners must be postmenopausal (defined as 12 months of amenorrhea following last menses);
- Willing and able to comply with study scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Any evidence of mixed histo- and/or cytology that includes elements of small cell or carcinoid lung cancer. Variations of adenocarcinoma are allowed, however no squamous element can be present;
- An EGFR exon 20 T790M or exon 20 insertion mutation;
- Symptomatic brain or leptomeningeal metastases, who are neurologically unstable or require increasing doses of steroids and/or anti-seizure medications to manage CNS symptoms within two weeks prior to starting dacomitinib;
- Any previous anti-cancer systemic treatment of locally advanced, or metastatic NSCLC including but not limited to chemotherapy, targeted therapies, small molecules, EGFR-TKIs and other TKIs, monoclonal antibodies, anti-cancer vaccines, immunotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, i.e., non-target lesions). Completed neoadjuvant/adjuvant chemotherapy/immunotherapy and/or combined modality chemotherapy/ radiation therapy permitted only in cases in which there is a minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC. Prior treatment with a EGFR-TKI or other TKIs is not allowed;
- Any surgery (not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments;
- Any clinically significant gastrointestinal abnormalities that may impair intake, transit or absorption of the study drug, such as the inability to take oral medication;
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- Current enrollment in another therapeutic clinical study;
- Any psychiatric or cognitive disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this study; or known drug abuse/alcohol abuse;
- History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial lung disease including:
- Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease;
- Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline;
- Insufficient lung function as determined by either clinical examination or an arterial oxygen tension of <70 Torr.
- Any history of rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Clinically important abnormalities in cardiac rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, second degree heart block, third degree heart block) OR:
- Diagnosed or suspected congenital long QT syndrome;
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
- Prolonged QTc interval on ECG; QTc must be less than CTCAE v5.0 Grade 2 (≤480 msec) using Fridericia's or Bazett's correction formula with a manual reading by the investigator if required. The ECG may be repeated for evaluation of eligibility after management of correctable causes for observed QTc prolongation;
- Any history of second or third degree heart block;
- Heart rate <45 beats per minute on ECG in the presence of clinical symptoms (e.g., hypotension, evidence of hypoperfusion);
- Severely impaired (defined as Child-Pugh Class C) hepatic dysfunction;
- Prior malignancy: Subjects will not be eligible if they have history of, or evidence of active disease of another concurrent malignancy within the previous five years. Exception would be effectively treated past history of non-melanoma skin cancer or in-situ cervical cancer with no evidence of active disease;
- Other severe acute or chronic medical condition that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study;
- Use of CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities, including but not limited to procainamide, pimozide, and thioridazine from screening to randomization.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Malaysia3 sites
University Malaya Medical Centre
Kuala Lumpur
Sarawak General Hospital
Kuching, Sarawak
Beacon Hospital
Petaling Jaya
South Korea2 sites
Dong-A University Hospital
Busan
Seoul National University Hospital
Seoul
About this study
Official title: 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
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.
- Conditions
- NSCLC Stage IIIB, NSCLC Stage IIIC, NSCLC Stage IV, Recurrent NSCLC, EGFR Positive Non-Small Cell Lung Cancer
- Being tested
- Dacomitinib
- Keywords
- Stage III NSCLC, Stage IV NSCLC, Vizimpro, EGFR TKI, Tyrosine Kinase Inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacomitinibDrug
Also called Vizimpro
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Daily administration of oral Dacomitinib Receives: Drug: Dacomitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Percentage of subjects with PFS at 12 months
Measured: From the start of treatment to the date of disease progression or death due to any cause at 12 months
Secondary outcomes (6)
Overall Survival
Measured: From the start of treatment to the date of death for any cause, up to 3 years
Objective Response Rate
Proportion of subjects with a best overall response of either complete response (CR) or partial response (PR)
Measured: From the start of treatment until disease progression, up to 3 years
Time to Treatment Failure
Measured: From the start of treatment to the last dose of treatment, up to 3 years
Intracranial Objective Response Rate
Proportion of subjects with a best overall response of either CR or PR of intracranial disease
Measured: From the start of treatment until disease progression, up to 3 years
Intracranial Progression-Free Survival
Measured: From the start of treatment to the date of intracranial progression or death due to any cause, up to 3 years
Number of incidences of adverse events
Measured: From start of treatment to 28 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start11 Sep 2019
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIIBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Daniel Tan, BSc, MBBS, PhD, Principal investigator, National Cancer Centre Singapore (Lead Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027647
- Sponsor's protocol ID
- ATORG-003
- Status last verified
- Jun 2025
- First submitted
- 18 Jul 2019
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04027647
- Acronym / sponsor ID
- ATORG-003
- Conditions
- NSCLC Stage IIIB, NSCLC Stage IIIC, NSCLC Stage IV, Recurrent NSCLC, EGFR Positive Non-Small Cell Lung Cancer
- Keywords
- Stage III NSCLC, Stage IV NSCLC, Vizimpro, EGFR TKI, Tyrosine Kinase Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: DacomitinibDaily administration of oral Dacomitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provision of a voluntarily given, personally signed and dated, written informed consent document;
- Male or female adult as defined by local regulation;
- The presence of an EGFR activating mutation (exon 19 deletion or the L858R mutation in exon 21) in tumor specimen determined by the local laboratory;
- Evidence of newly diagnosed stage IIIB/IIIC/IV (based on Union for International Cancer Control (UICC) staging system version 8) or recurrent (minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC required) NSCLC of adenocarcinoma histo- and/or cytopathology or its pathologically accepted variants using tumor specimen (assessed according to accepted standards by a local laboratory). For this purpose the World Health Organization/International Association of Study of Lung Cancer Histologic Classification of Lung Cancer Criteria will be used and the diagnosis of NSCLC NOS (not otherwise specified), squamous or mixed adeno-squamous lung carcinomas will not be allowed;
- Have an ECOG PS of 0 or 1;
Key exclusion criteria (23 listed)
- Any evidence of mixed histo- and/or cytology that includes elements of small cell or carcinoid lung cancer. Variations of adenocarcinoma are allowed, however no squamous element can be present;
- An EGFR exon 20 T790M or exon 20 insertion mutation;
- Symptomatic brain or leptomeningeal metastases, who are neurologically unstable or require increasing doses of steroids and/or anti-seizure medications to manage CNS symptoms within two weeks prior to starting dacomitinib;
- Any previous anti-cancer systemic treatment of locally advanced, or metastatic NSCLC including but not limited to chemotherapy, targeted therapies, small molecules, EGFR-TKIs and other TKIs, monoclonal antibodies, anti-cancer vaccines, immunotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, i.e., non-target lesions). Completed neoadjuvant/adjuvant chemotherapy/immunotherapy and/or combined modality chemotherapy/ radiation therapy permitted only in cases in which there is a minimum of 12 months disease free interval between completion of systemic therapy and recurrence of NSCLC. Prior treatment with a EGFR-TKI or other TKIs is not allowed;
- Any surgery (not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DacomitinibAlso: Vizimpro30mg 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. | Drug | Treatment |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the start of treatment to the date of disease progression or death due to any cause at 12 months
Percentage of subjects with PFS at 12 months
6 secondary outcomes
Overall Survival
Time frame: From the start of treatment to the date of death for any cause, up to 3 years
Objective Response Rate
Time frame: From the start of treatment until disease progression, up to 3 years
Time to Treatment Failure
Time frame: From the start of treatment to the last dose of treatment, up to 3 years
Intracranial Objective Response Rate
Time frame: From the start of treatment until disease progression, up to 3 years
Intracranial Progression-Free Survival
Time frame: From the start of treatment to the date of intracranial progression or death due to any cause, up to 3 years
Number of incidences of adverse events
Time frame: From start of treatment to 28 days after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Tan, BSc, MBBS, PhD principal investigator
National Cancer Centre Singapore (Lead Sponsor)
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dacomitinib in people with NSCLC Stage IIIB and NSCLC Stage IIIC, run by National Cancer Centre, Singapore at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Malaysia, South Korea, Thailand, Hong Kong, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the start of treatment to the date of disease progression or death due to any cause at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025; AzTrials last refreshed its copy on 2 Nov 2026.