Lung CancerPhase 2TIMEDNCT07630168
Effects of Infusion Timing on Treatment Response in Solid Tumors
A Phase 2 study testing PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM, PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM and PD-1 inhibitor monotherapy - 2 cycles before 12:00PM in people with Lung Cancer and Non-small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer, Metastatic Lung Cancer
- What is being tested?
- PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM, PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM and PD-1 inhibitor monotherapy - 2 cycles before 12:00PM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 1 Jan 2033
- 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
- Cohort 1A and 1B:
- Participants with metastatic non-small cell lung cancer (NSCLC).
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years at the time of consent.
- Cohort 2A and 2B:
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- Participants with resectable head and neck squamous cell carcinoma (HNSCC)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement
- of the investigator.
- Age ≥ 18 years at the time of consent.
Who cannot join
- Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.
- Prior immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening.
- Subject is participating in another treatment clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
Adrianna Warner, 919-984-0000, Adrianna_warner@med.unc.edu
Shetal A Patel, MD
About this study
Official title: Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors
This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer, Metastatic Lung Cancer, Head and Neck Cancer, Metastatic Squamous Cell Carcinoma, Metastatic Head and Neck Cancer
- Being tested
- PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM, PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM, PD-1 inhibitor monotherapy - 2 cycles before 12:00PM, PD-1 inhibitor monotherapy - 2 cycles after 3 PM
- Keywords
- programmed cell death protein 1, programmed death-ligand 1
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PMDrug
PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered before 12:00PM for 4 cycles.
PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PMDrug
PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered after 3 PM for 4 cycles.
PD-1 inhibitor monotherapy - 2 cycles before 12:00PMDrug
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles.
PD-1 inhibitor monotherapy - 2 cycles after 3 PMDrug
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM | Experimental | Patients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment before 12:00 PM. Receives: Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM |
| Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM | Experimental | Patients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment after 3:00 PM. Receives: Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM |
| Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM | Experimental | Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment before 12:00 PM. Receives: Drug: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM |
| Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM | Experimental | Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC)eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment after 3:00 PM. Receives: Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) - non-small cell lung cancer (NSCLC)
Progression free survival (PFS) will be measured as the time from the date of randomization to the earliest date of radiographic disease progression (PD), as determined by RECIST 1.1, or death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).
Measured: Up to 2 years
Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).
Major Pathologic Response (MPR) is defined as participant with ≤10% viable tumor in resected tumor tissue in patients with resectable head and neck squamous cell carcinoma (HNSCC).
Measured: Up to 3 months
Secondary outcomes (3)
Overall survival (OS) - non-small cell lung cancer (NSCLC)
Overall survival (OS) is defined as the time from randomization to death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).
Measured: Up to 2 years
Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)
Objective Response Rate defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 To determine if time of day of immune checkpoint inhibitor administration impacts treatment response in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).
Measured: Up to 2 years
Timing of surgery
Timing of surgery is defined as the time from the last neoadjuvant dose to the date of surgery.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start3 Aug 2026
- Primary completion1 Jan 2033 (estimated)
- Study completion1 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shetal A Patel, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630168
- Sponsor's protocol ID
- LCCC2526-DCT
- Acronym
- TIMED
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 15 Sep 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors
- ClinicalTrials.gov ID
- NCT07630168
- Acronym / sponsor ID
- TIMED / LCCC2526-DCT
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer, Metastatic Lung Cancer, Head and Neck Cancer, Metastatic Squamous Cell Carcinoma, Metastatic Head and Neck Cancer
- Keywords
- programmed cell death protein 1, programmed death-ligand 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 1 Jan 2033 (estimated)
- First posted
- 5 Jun 2026 (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 study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM | Experimental | Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PMPatients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment before 12:00 PM. |
| Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM | Experimental | Drug: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PMPatients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment after 3:00 PM. |
| Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM | Experimental | Drug: PD-1 inhibitor monotherapy - 2 cycles before 12:00PMPatients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment before 12:00 PM. |
| Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM | Experimental | Drug: PD-1 inhibitor monotherapy - 2 cycles after 3 PMPatients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC)eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment after 3:00 PM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants with metastatic non-small cell lung cancer (NSCLC).
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator.
- Age ≥ 18 years at the time of consent.
- Participants with resectable head and neck squamous cell carcinoma (HNSCC)
Key exclusion criteria (3 listed)
- Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.
- Prior immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening.
- Subject is participating in another treatment clinical trial.
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 |
|---|---|---|
| PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PMPD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered before 12:00PM for 4 cycles. | Drug | Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM |
| PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PMPD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered after 3 PM for 4 cycles. | Drug | Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM |
| PD-1 inhibitor monotherapy - 2 cycles before 12:00PMPD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles. | Drug | Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM |
| PD-1 inhibitor monotherapy - 2 cycles after 3 PMPD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles. | Drug | Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM |
Primary outcome
Progression free survival (PFS) - non-small cell lung cancer (NSCLC)
Time frame: Up to 2 years
Progression free survival (PFS) will be measured as the time from the date of randomization to the earliest date of radiographic disease progression (PD), as determined by RECIST 1.1, or death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).
Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).
Time frame: Up to 3 months
Major Pathologic Response (MPR) is defined as participant with ≤10% viable tumor in resected tumor tissue in patients with resectable head and neck squamous cell carcinoma (HNSCC).
3 secondary outcomes
Overall survival (OS) - non-small cell lung cancer (NSCLC)
Time frame: Up to 2 years
Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)
Time frame: Up to 2 years
Timing of surgery
Time frame: Up to 3 months
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 15 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- 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.
Shetal A Patel, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM, PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM and PD-1 inhibitor monotherapy - 2 cycles before 12:00PM in people with Lung Cancer and Non-small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 11 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Sep 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 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 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?
Contact Adrianna Warner (919-984-0000, Adrianna_warner@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) - non-small cell lung cancer (NSCLC) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 15 Sep 2026.