Non-Small Cell Lung CancerPhase 1/2NCT03122717
Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
A Phase 1/2 study testing Gefitinib and Osimertinib in people with Non-Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The interventions involved in this study are: Osimertinib (Tagrisso) Gefitinib (Iressa) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Gefitinib and Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 May 2017to Oct 2027
- Phase
- Phase 1/2
- 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
- Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory. Note: recurrent stage IV disease initially diagnosed at an earlier stage is considered eligible, provided prior treatment criteria is met.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Participants can have no prior history of any EGFR-directed therapy, including TKIs or antibodies, and must also be chemotherapy and immunotherapy naïve. Patients who have completed adjuvant or neo-adjuvant chemotherapy or immunotherapy >6 months ago are considered treatment naive.
- Participants must be aged ≥ 18 years
- Participants must have an ECOG performance status of 0-1 (Appendix A)
- Participants must have a life expectancy of greater than 12 weeks
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- Participants must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- hemoglobin >9.0 g/dL
- total bilirubin < 1.5 times the ULN if no liver metastases or < 3 times the ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases
- AST(SGOT)/ALT(SGPT) <2.5 × institutional upper limit of normal or <5 times the ULN in the presence of liver metastases
- creatinine within normal institutional limits OR
- creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Participants should have biopsy tissue at time of diagnosis available for next-generation sequencing testing at the Dana-Farber Cancer Institute. Biopsy can be performed at an outside institution as long as sufficient tissue is available. If next generation sequencing has already been performed prior to study enrollment it does not need to be repeated. Note: Cytology specimen may be acceptable for baseline NGS if tumor cellular content is sufficient and following PI approval. If there is no cytology specimen or tissue sample available for NGS, plasma-based NGS may be acceptable for enrollment following discussion with PI.
- Participants must be ≥4 weeks since any major surgery (excluding vascular access placement, mediastinoscopy, or biopsies performed by an interventional service)
- Participants must be ≥2 weeks since any prior radiation, including CNS radiation
- Male patients: Willing to use adequate contraception (barrier or abstinence) while on treatment with study drug and for 3 months after finishing treatment.
- Female patients: Willing to use adequate contraception (barrier or abstinence) while on treatment with study drug and for 3 months after finishing treatment.
- Female patients: Must not be pregnant or breast-feeding. Women of child-bearing potential must have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior or ongoing treatment with any of the following:
- EGFR targeted therapy (TKI or antibody) or any other targeted therapies targeting the ERBB family
- Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for the treatment of metastatic NSCLC
- Prior radiotherapy within 2 weeks of the first dose of study treatment. Patients who have received radiation to more than 25% of the bone marrow are not eligible at any time.
- No uncontrolled central nervous system (CNS) disease, including parenchymal brain metastases, leptomeningeal disease, or spinal cord compression. Patients with asymptomatic untreated brain metastases are eligible. Patients with treated CNS disease will be allowed to enroll provided they have clinically confirmed stable disease with ≥2 weeks since definitive CNS therapy (radiation or surgery) and ≥2 weeks without systemic steroids. Patients may undergo either whole brain radiation or stereotactic radiosurgery prior to study entry.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib or osimertinib.
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- Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (Appendix B). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4. The full list of medications that would make a patient ineligible are provided in Appendix B.
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment.
- Malignancies within the past 3 years excluding adequately treated basal or squamous cell carcinomas of the skin without local or distant metastases.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, previous significant bowel resection, or any process that compromises the ability to swallow or absorb oral medication
- Significant medical history or unstable medical comorbidities, including:
- heart disease including congestive heart failure (NYHA Grade II or greater); unstable angina; prior myocardial infarction (NSTEMI or STEMI) within 6 months prior to study enrollment; hypertension with a systolic blood pressure of >150 mm Hg or diastolic blood pressure of >100 mm Hg while on antihypertensive medication
- any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250msec, mean resting corrected QT value (QTc) of >470msec
- any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, or any concomitant medication known to the prolong the QT interval
- past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
- active infection or ongoing antiviral medication for viral infections including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Screening for chronic conditions is not required. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with gefitinib or osimertinib.
- ongoing use of warfarin (injectable low-molecular weight heparins are permitted). Patients must be off warfarin for >7 days prior to enrollment
- Identification of EGFR T790M in baseline cfDNA analysis
- Active pregnancy or breast-feeding.
- Pregnant women are excluded from this study because the effects of gefitinib and osimertinib on the development of the fetus are unknown, and there is potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with gefitinib or osimertinib, breastfeeding should be discontinued if the mother is treated with these agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase 1/2 Study of Osimertinib in Combination With Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.
The interventions involved in this study are:
- Osimertinib (Tagrisso)
- Gefitinib (Iressa)
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of investigational drugs and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has approved gefitinib and osimertinib as separate treatment options for this disease. The FDA has not approved the combination of these study drugs as a treatment option for this disease.Recently, the FDA approved osimertinib as a first-line treatment for patients that have NSCLC with an EGFR mutation, that have not received prior treatment for their disease.
In this research study, the investigators are evaluating the combination of gefitinib and osimertinib in patients who have just been diagnosed with non-small cell lung cancer containing a mutation in the epidermal growth factor receptor (EGFR) gene.
Normally, cells in the body divide in an orderly way. However, in cancer cells, this normal process of cell division becomes abnormal and allows the cancer cells to grow in a rapid, unregulated way. In some patients with lung cancer, this abnormal and rapid growth in the cancer cells is drive by a specific change in a gene called the Epidermal Growth Factor Receptor (EGFR). This change in the EGFR gene in cancer cells is called a mutation. Patients with lung cancer harboring a mutation in EGFR can be treated with specific drugs called EGFR inhibitors. However, even though these drugs can be very effective, after a period of time, most EGFR tumors will develop resistance to this treatment, most often because of a second mutation in EGFR called T790M.
Right now, patients with newly diagnosed lung cancer with an EGFR mutation would be treated with a single EGFR inhibitor. A drug like gefitinib is a standard first treatment for patients with this kind of lung cancer. Osimertinib is currently approved only to treat patients whose cancers develop resistance to gefitinib (or other similar EGFR inhibitors) because of the T790M mutation.
However, ongoing clinical trials have shown that osimertinib is also effective when used as the first treatment in newly diagnosed patients with lung cancer containing an EGFR mutation. In addition, laboratory studies have shown that combining EGFR inhibitors may help prevent the development of drug resistance.
The goal of this particular study is to evaluate two different methods of combining gefitinib and osimertinib in newly diagnosed patients with EGFR mutations: either with both drugs given together on the same day OR an alternating schedule where participants will alternate taking one drug at a time every 4 weeks.
This study will help determine the optimal dosing strategy for combining these two drugs in lung cancer patients with EGFR mutations. The study will also follow the clinical response of participants treated with the drug combination to monitor how well and how long this strategy controls the disease.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Gefitinib, Osimertinib
- Keywords
- Non-Small Cell Lung Cancer
- 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.
GefitinibDrug
Also called Iressa
gefitinib is a EGFR inhibitor
OsimertinibDrug
Also called Tagrisso
An orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib + Osimertinib | Experimental | * Gerfitinib will administered orally at a pre determine dose daily
* Osimertinib will administered orally at a pre determine dose daily Receives: Drug: Gefitinib; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles
The feasibility of combination gefitinib/osimertinib dosing will be determined through evaluation of the number of patients in each cohort who are able to remain on combination therapy for 6 x 28 day cycles.
Measured: 3 years
Secondary outcomes (4)
Rate of treatment-related Grade 3-5 adverse events
CTCAE v4.0 will be used to monitor toxicities in patients on combination therapy with gefitinib and osimertinib.
Measured: 3 years
Objective response rate
RECIST 1.1 measurements of CT scans of the chest/abdomen/pelvis will be measured every 2 cycles on treatment to determine the objective response rate for patients being treated with combination gefitinib and osimertinib.
Measured: 3 years (each cycle is 28 days)
Progression free survival
The Kaplan-Meier method will be used to determine the progression-free survival of patients enrolled on protocol and treated with combination gefitinib and osimertinib.
Measured: 3 years
Overall Survival
Survival follow-up with clinic visits or phone calls will be used to monitor for overall survival from time of study randomization to death from any cause. The Kaplan-Meier method will be used to calculate overall survival.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start9 May 2017
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Pasi Janne, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Pasi Janne, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122717
- Sponsor's protocol ID
- 16-627
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2017
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Osimertinib in Combination With Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
- ClinicalTrials.gov ID
- NCT03122717
- Acronym / sponsor ID
- 16-627
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 9 May 2017 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Apr 2017 (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 research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.
The interventions involved in this study are:
- Osimertinib (Tagrisso)
- Gefitinib (Iressa)
Detailed description
This research study is a Phase I clinical trial, which tests the safety of investigational drugs and also tries to define the appropriate dose of the investigational drugs to use for further studies. "Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has approved gefitinib and osimertinib as separate treatment options for this disease. The FDA has not approved the combination of these study drugs as a treatment option for this disease.Recently, the FDA approved osimertinib as a first-line treatment for patients that have NSCLC with an EGFR mutation, that have not received prior treatment for their disease.
In this research study, the investigators are evaluating the combination of gefitinib and osimertinib in patients who have just been diagnosed with non-small cell lung cancer containing a mutation in the epidermal growth factor receptor (EGFR) gene.
Normally, cells in the body divide in an orderly way. However, in cancer cells, this normal process of cell division becomes abnormal and allows the cancer cells to grow in a rapid, unregulated way. In some patients with lung cancer, this abnormal and rapid growth in the cancer cells is drive by a specific change in a gene called the Epidermal Growth Factor Receptor (EGFR). This change in the EGFR gene in cancer cells is called a mutation. Patients with lung cancer harboring a mutation in EGFR can be treated with specific drugs called EGFR inhibitors. However, even though these drugs can be very effective, after a period of time, most EGFR tumors will develop resistance to this treatment, most often because of a second mutation in EGFR called T790M.
Right now, patients with newly diagnosed lung cancer with an EGFR mutation would be treated with a single EGFR inhibitor. A drug like gefitinib is a standard first treatment for patients with this kind of lung cancer. Osimertinib is currently approved only to treat patients whose cancers develop resistance to gefitinib (or other similar EGFR inhibitors) because of the T790M mutation.
However, ongoing clinical trials have shown that osimertinib is also effective when used as the first treatment in newly diagnosed patients with lung cancer containing an EGFR mutation. In addition, laboratory studies have shown that combining EGFR inhibitors may help prevent the development of drug resistance.
The goal of this particular study is to evaluate two different methods of combining gefitinib and osimertinib in newly diagnosed patients with EGFR mutations: either with both drugs given together on the same day OR an alternating schedule where participants will alternate taking one drug at a time every 4 weeks.
This study will help determine the optimal dosing strategy for combining these two drugs in lung cancer patients with EGFR mutations. The study will also follow the clinical response of participants treated with the drug combination to monitor how well and how long this strategy controls the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefitinib + Osimertinib | Experimental | Drug: Gefitinib, Drug: Osimertinib* Gerfitinib will administered orally at a pre determine dose daily * Osimertinib will administered orally at a pre determine dose daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory. Note: recurrent stage IV disease initially diagnosed at an earlier stage is considered eligible, provided prior treatment criteria is met.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Participants can have no prior history of any EGFR-directed therapy, including TKIs or antibodies, and must also be chemotherapy and immunotherapy naïve. Patients who have completed adjuvant or neo-adjuvant chemotherapy or immunotherapy >6 months ago are considered treatment naive.
- Participants must be aged ≥ 18 years
- Participants must have an ECOG performance status of 0-1 (Appendix A)
Key exclusion criteria (21 listed)
- Prior or ongoing treatment with any of the following:
- Prior radiotherapy within 2 weeks of the first dose of study treatment. Patients who have received radiation to more than 25% of the bone marrow are not eligible at any time.
- No uncontrolled central nervous system (CNS) disease, including parenchymal brain metastases, leptomeningeal disease, or spinal cord compression. Patients with asymptomatic untreated brain metastases are eligible. Patients with treated CNS disease will be allowed to enroll provided they have clinically confirmed stable disease with ≥2 weeks since definitive CNS therapy (radiation or surgery) and ≥2 weeks without systemic steroids. Patients may undergo either whole brain radiation or stereotactic radiosurgery prior to study entry.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib or osimertinib.
- Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (Appendix B). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4. The full list of medications that would make a patient ineligible are provided in Appendix B.
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 |
|---|---|---|
| GefitinibAlso: Iressagefitinib is a EGFR inhibitor | Drug | Gefitinib + Osimertinib |
| OsimertinibAlso: TagrissoAn orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor | Drug | Gefitinib + Osimertinib |
Primary outcome
Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles
Time frame: 3 years
The feasibility of combination gefitinib/osimertinib dosing will be determined through evaluation of the number of patients in each cohort who are able to remain on combination therapy for 6 x 28 day cycles.
4 secondary outcomes
Rate of treatment-related Grade 3-5 adverse events
Time frame: 3 years
Objective response rate
Time frame: 3 years (each cycle is 28 days)
Progression free survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Pasi Janne, MD, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gefitinib and Osimertinib in people with Non-Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 25 inclusion and 21 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles (time frame: 3 years). 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 21 Oct 2026.