Squamous Cell CarcinomaPhase 2NCT03486509
Afatinib Plus Chemotherapy Against Esophageal or Lung Squamous Cell Carcinoma
A Phase 2 study testing Afatinib in people with Squamous Cell Carcinoma, run by Fujian Cancer Hospital.
Trial summary
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- Afatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 1 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
- Life expectancy > 10 months
- Karnofsky Performance Status ≥ 70
- Diagnosis of histological or cytologically confirmed squamous lung cancer or esophageal squamous cancer,
- Age ≥ 18 years
- Adequate organ and bone marrow function, defined as: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin > 9 g/dL; platelets > 100 x 109/L Renal: creatinine clearance ≥ 50 mL/min (calculated according to Cockroft and Gault) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); internation normalized value for prothrombin time (INR) ≤ 1.5 x ULN (except in the case of anticoagulation therapy), albumin ≥ 2.0
- Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
Who cannot join
- Poor compliance, reluctant to undergo research medication, or follow-up.
- Tumor inaccessible for biopsy
- It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
- It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
About this study
Official title: Phase II Study of Afatinib Plus Chemotherapy in Patients With Esophageal and Lung Squamous Cell Carcinoma
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression.
The overall results from previous studies of gefitinib and erlotinib as EGFR TKIs , as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.
Read the detailed description
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, In a phase III study LUX-lung 8 in patients with squamous lung cancer, afatinib monotherapy showed longer progression-free disease survival than erlotinib therapy. afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty (30) solid cancer patients were included in a phase I trial of afatinib, and of them, a patient with esophageal cancer had partial response. Taken together, based upon the results from clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients achieved clinical responses of 3 months or longer.
Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Afatinib
- Keywords
- afatinib
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
afatinb 40mg po bid
| Study group | Role | What they receive |
|---|---|---|
| afatinib 40mg bid plus chemotherapy | Experimental | afatinib 40mg bid po plus chemotherapy Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free-Survival
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
ORR
objective response rate
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486509
- Sponsor's protocol ID
- CSWOG201702
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Afatinib Plus Chemotherapy in Patients With Esophageal and Lung Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03486509
- Acronym / sponsor ID
- CSWOG201702
- Conditions
- Squamous Cell Carcinoma
- Keywords
- afatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 3 Apr 2018 (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.
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression.
The overall results from previous studies of gefitinib and erlotinib as EGFR TKIs , as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.
Detailed description
As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, In a phase III study LUX-lung 8 in patients with squamous lung cancer, afatinib monotherapy showed longer progression-free disease survival than erlotinib therapy. afatinib is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty (30) solid cancer patients were included in a phase I trial of afatinib, and of them, a patient with esophageal cancer had partial response. Taken together, based upon the results from clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients achieved clinical responses of 3 months or longer.
Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer or squmaous lung cancer. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus or lung squamous cell carcinoma to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| afatinib 40mg bid plus chemotherapy | Experimental | Drug: Afatinibafatinib 40mg bid po plus chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures
- Life expectancy > 10 months
- Karnofsky Performance Status ≥ 70
- Diagnosis of histological or cytologically confirmed squamous lung cancer or esophageal squamous cancer,
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Poor compliance, reluctant to undergo research medication, or follow-up.
- Tumor inaccessible for biopsy
- It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.
- It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years.
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 |
|---|---|---|
| Afatinibafatinb 40mg po bid | Drug | afatinib 40mg bid plus chemotherapy |
Primary outcome
PFS
Time frame: through study completion, an average of 2 year
Progression-Free-Survival
1 secondary outcome
ORR
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afatinib in people with Squamous Cell Carcinoma, run by Fujian Cancer Hospital.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
PFS (time frame: through study completion, an average of 2 year). 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 3 Apr 2018.