Carcinoma, Non-Small-Cell LungFOREFRONTNCT06376084
Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by AstraZeneca at 1 site in China.
Trial summary
To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms
- How many people
- 532 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2024to 28 Feb 2028
- Phase
- Observational
- 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
Study population: Patients with locally advanced or metastatic, EGFR mutation-positive (Ex19del and/or 21 L858R) NSCLC who receive Osimertinib plus chemotherapy as the first-line therapy based on physician's medical assessment will be enrolled. Approximately 700 patients will be enrolled from about 60 sites in China.
Who may be able to join
- Age ≥18 years
- Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation.
- EGFR sensitive mutation-positive (Ex19del and/or 21 L858R)
- WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks.
- Patients who receive Osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (For patients who received prior chemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months).
- Patients with asymptomatic CNS metastases or patients who have completed definitive therapy, are not on steroids and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids are allowed.
- Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.
Who cannot join
- Spinal cord compression and symptomatic brain metastases
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc
- Any banned substance in label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osimertinib With Chemotherapy as First-line Therapy for Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-Small Cell Lung Cancer (NSCLC): A Multicentre, Observational Study (FOREFRONT)
To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS .
Read the detailed description
The objectives of this study are to assess the effectiveness and safety of Osimertinib combined with chemotherapy in a real-world setting in patients with locally advanced or metastatic, EGFR mutation-positive NSCLC.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms
- Keywords
- Osimertinib, Epidermal Growth Factor Receptor, NSCLC, Non-small cell lung cancer, Observational
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-World Progression Free Survival (rwPFS)
rwPFS is defined as the time from the date of first-line initiation until disease progression or death by investigator report as recorded in the CRF
Measured: Follow up approximately 36 months after last patient in
Secondary outcomes (5)
Chemotherapy regimen
Chemotherapy information i.e. dose, number of induction chemotherapy cycles and duration of chemotherapy maintenance, any dose changes and reasons for these changes and date of last administration will also be recorded.
Measured: Follow up approximately 36 months after last patient in
Duration of chemotherapy (induction and maintenance cycles)
Duration of first-line Osimertinib plus chemotherapy, and duration of initial therapy prior to first-line Osimertinib plus chemotherapy (i.e., prior Osimertinib only, prior chemotherapy only).
Measured: Follow up approximately 36 months after last patient in
Response rate
Response rate (RR) is defined as the percentage of patients with the best response of "responding" by investigator report as recorded in CRF. Patients who discontinue treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the RR calculation.
Measured: Follow up approximately 36 months after last patient in
Duration of response
DoR: is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. The end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing toward the first visit response. If a patient does not progress following a response, then his/her duration of response will use the PFS censoring time as the end point for their DoR calculation.
Measured: Follow up approximately 36 months after last patient in
Overall survival (OS)
OS is defined as the time from the first-line initiation until death due to any cause regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy.
Measured: Follow up approximately 36 months after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start23 Jul 2024
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baohui HAN, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376084
- Sponsor's protocol ID
- D5161R00055
- Acronym
- FOREFRONT
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Publications
Zhang B, Ning F, Liu X, Li N, Wang P, Yao W, Han B, Wang Q, Zhong H. First-line therapy of osimertinib with chemotherapy in Chinese patients with EGFR mutation-positive non-small cell lung cancer: protocol for a multicenter, prospective, observational study. Front Oncol. 2025 Sep 5;15:1625714. doi: 10.3389/fonc.2025.1625714. eCollection 2025.
PubMed 40978050
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osimertinib With Chemotherapy as First-line Therapy for Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-Small Cell Lung Cancer (NSCLC): A Multicentre, Observational Study (FOREFRONT)
- ClinicalTrials.gov ID
- NCT06376084
- Acronym / sponsor ID
- FOREFRONT / D5161R00055
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms
- Keywords
- Osimertinib, Epidermal Growth Factor Receptor, NSCLC, Non-small cell lung cancer, Observational
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 532 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 Apr 2024 (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.
To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS .
Detailed description
The objectives of this study are to assess the effectiveness and safety of Osimertinib combined with chemotherapy in a real-world setting in patients with locally advanced or metastatic, EGFR mutation-positive NSCLC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or metastatic, EGFR mutation-positive (Ex19del and/or 21 L858R) NSCLC who receive Osimertinib plus chemotherapy as the first-line therapy based on physician's medical assessment will be enrolled. Approximately 700 patients will be enrolled from about 60 sites in China.
Key inclusion criteria (8 listed)
- Age ≥18 years
- Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation.
- EGFR sensitive mutation-positive (Ex19del and/or 21 L858R)
- WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks.
Key exclusion criteria (4 listed)
- Spinal cord compression and symptomatic brain metastases
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc
- Any banned substance in label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-World Progression Free Survival (rwPFS)
Time frame: Follow up approximately 36 months after last patient in
rwPFS is defined as the time from the date of first-line initiation until disease progression or death by investigator report as recorded in the CRF
5 secondary outcomes
Chemotherapy regimen
Time frame: Follow up approximately 36 months after last patient in
Duration of chemotherapy (induction and maintenance cycles)
Time frame: Follow up approximately 36 months after last patient in
Response rate
Time frame: Follow up approximately 36 months after last patient in
Duration of response
Time frame: Follow up approximately 36 months after last patient in
Overall survival (OS)
Time frame: Follow up approximately 36 months after last patient in
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 18 Aug 2026.
- Derived from this study: PubMed 40978050Zhang B, Ning F, Liu X, Li N, Wang P, Yao W, Han B, Wang Q, Zhong H. First-line therapy of osimertinib with chemotherapy in Chinese patients with EGFR mutation-positive non-small cell lung cancer: protocol for a multicenter, prospective, observational study. Front Oncol. 2025 Sep 5;15:1625714. doi: 10.3389/fonc.2025.1625714. eCollection 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
Baohui HAN principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by AstraZeneca at 1 site in China.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
Real-World Progression Free Survival (rwPFS) (time frame: Follow up approximately 36 months after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376084, which also lists 1 linked publication.
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 18 Aug 2026.