NSCLC clinical trial software
Lung cancer trials turn on dates: the scan, the progression, the surgery, the last known alive. Capture records tumour assessments, biomarker strata and immune-related safety with an audit trail on every field. Test the build free.
- Tumour assessment by timepoint
- Biomarker strata
- Survival follow-up
Free sandbox · No credit card · 21 CFR Part 11 compliant
Biomarkers confirmed, randomised
Histology, PD-L1 category, driver mutation status
Neoadjuvant cycles
Dose, delays, adverse events by cycle
Surgery and pathology
Date, resection status, pathology response entered from report
- 4
Adjuvant phase and imaging
Scans at protocol intervals, recurrence date
- 5
Survival follow-up
Contact date, status, subsequent therapy
What an NSCLC trial needs from its EDC
- The disease setting decides the endpoint: advanced disease trials usually report progression-free survival and overall survival; perioperative designs report event-free survival with pathological response (pathological complete response or major pathological response); adjuvant designs report disease-free survival.
- Biomarkers define the cohort: histology (squamous versus non-squamous), PD-L1 expression category and driver alterations such as EGFR, ALK, ROS1 or KRAS G12C often decide arm, stratum or eligibility. They are examples, not a protocol: use yours.
- Scan dates are primary data: the date of each imaging assessment, the date of first documented progression and the reader (investigator or central) must be stored exactly, since time-to-event analyses are built from them.
- Immune-related and treatment-related safety: pneumonitis, colitis, hepatitis, endocrinopathies and infusion reactions need onset, grade, treatment and outcome, graded by a named CTCAE version.
- Long, event-driven follow-up: after progression, participants are followed for survival and subsequent therapy, often by phone, and the study may run for years.
Endpoints by setting
Setting, endpoint, and the fields each one needs
Registered perioperative immunotherapy programmes show how much the setting changes the data. IMpower030 (atezolizumab), KEYNOTE-671 (pembrolizumab), RATIONALE 315 (tislelizumab) and CheckMate 816 (nivolumab) used event-free survival, with pathological complete response and major pathological response read by a blinded central pathologist as co-primary or key secondary measures in various combinations. Whether event-free survival is determined by blinded independent central review or investigator imaging differs between protocols, so that choice has to be written into your data flow rather than assumed. In advanced disease the typical pair is progression-free survival and overall survival, with objective response rate and duration of response added where a single-arm or accelerated design is used.
For the data model, every one of these is a derived analysis built from a few dated facts: randomisation date, the date of each scan, the response category at each scan, the date and type of first progression or recurrence, the surgery date, the pathology report date and result, the date of death or last known alive, and the reason a participant was censored. Capture has no RECIST calculator: the reader assigns response per RECIST 1.1 or your protocol, and the form stores the sum of target lesion diameters, the non-target and new-lesion assessments and the overall response. Edit checks catch the data errors that wreck survival analyses, for example a response date earlier than the baseline scan or a death date earlier than the last visit. See survival sample size calculator for planning event counts and clinical trial endpoints for definitions.
The most common design problem is the baseline: a CT or MRI done before consent, outside the allowed window, or at a different centre. A visit window on the baseline scan plus a date-order rule against the informed consent date turns that into a query during enrolment, not a deviation found at database lock. Brain imaging belongs on the same schedule for protocols that track intracranial response separately. For setting up the visit schedule, schedule of assessments builder is a good start.
Biomarker and stratification data
Treat each biomarker as a field with a method, a result category, a test date and a sample source (tissue or plasma), because the same marker tested twice can differ. If randomisation is stratified by PD-L1 category or histology, the value entered must be the value used at randomisation, so lock that form before allocation. Capture supports randomization as part of the study; see EDC with randomization. Genomic panel results typically arrive as a report; enter the clinically relevant calls and keep the report with your study documents.
Scan date
RSDTCDays since randomisation
RSDYCalculated from the two dates
84 CalculatedSum of target lesion diameters
SLDNew lesions
NEWLESOverall response (assigned by reader)
OVRLRESPAssessed by
RSEVALProtocol to build
NSCLC protocol elements and how they map to Capture
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Histology and stage | Squamous or non-squamous, stage at entry, date of diagnosis | Medical history plus a disease-specific screening form |
| Biomarkers | Method, result category, date, sample source | Repeating rows so re-tests are kept, locked before randomisation |
| Performance status | ECOG 0 to 4 at each visit | ECOG performance status template |
| Tumour assessments | Target sum, non-target, new lesions, overall response | Imaging form per scan date with visit window |
| Pathology (perioperative) | Resection status, percent viable tumour, response category | Pathology form entered from the central or local report |
| Treatment cycles | Dose, delay, reduction, reason | Repeating rows per cycle with its own audit trail |
| Adverse events | Term, CTCAE grade, immune-related flag, outcome | Adverse event form and CTCAE grade lookup |
| Patient-reported outcomes | Symptoms, function, quality of life | EORTC QLQ-C30 layout, PRO-CTCAE, EQ-5D |
| Survival follow-up | Last contact date, status, subsequent therapy | Short follow-up form with a date-order check |
Instrument licences stay with your study documents; Capture does not supply licensed wording.
Build the tumour assessment form and run a mock scan schedule
Set up scan windows, enter a few fake progressions and a death, and check the date logic. Free sandbox, no credit card.
Safety and operations
Pneumonitis, immune-related events and keeping oncology sites on schedule
Lung cancer carries its own safety signals. Pneumonitis and interstitial lung disease are watched in several drug classes, and immune-related events can appear months after the last dose. A sound adverse event form therefore collects onset date, CTCAE grade, whether it is immune-related, the treatment given (steroids, interruption, discontinuation) and the outcome with a resolution date. Adverse events that meet seriousness criteria use the SAE report form and the deadlines in your protocol; the SAE reporting deadline calculator helps check the clock. See also adverse event reporting software.
Oncology sites juggle many scans, labs and cycles. Per-field source data verification can be set so monitors concentrate on the endpoint-critical items (scan dates, response, progression, death, dosing), and the query workflow keeps outstanding questions per site visible. The statistician usually needs only a few outputs to get started: the export with data dictionary, and SDTM datasets (SAS XPT with Define-XML) where the programme needs them. For broader oncology context, see EDC for oncology trials and ePRO for oncology.
Lung cancer patients may feel unwell and travel to appointments is hard, so ePRO diaries on the participant phone through a secure link, with reminders, can capture symptoms between visits, which a clinic form cannot. Whether a diary is allowed between cycles, and how its results feed the safety assessment, is a protocol question. Consent for a long programme with biomarker testing and possible future research should be explicit about tissue and genomic samples; the genomic research consent template shows the structure. Data are hosted in the EU (Frankfurt) or the USA (N. Virginia).
Before first participant
NSCLC study readiness checklist
Setting and endpoint mapped
PFS, EFS, DFS or response endpoint listed with the exact dates each needs.
Reader defined
Investigator or central assessment named on the imaging form, with a field for who assessed.
Baseline window enforced
Scan window against consent and randomisation dates, with a query on violations.
Biomarker locks planned
Stratification values frozen before allocation, with method and sample source.
Safety forms tested
Immune-related flag, CTCAE version and outcome entered for a mock pneumonitis case.
Censoring rules
Reasons for censoring and subsequent-therapy fields agreed with the statistician.
Does Capture assign RECIST response?
No. The reader assigns response under RECIST 1.1 or your protocol. Capture stores the target lesion sum, non-target and new-lesion assessments and the overall response with dates and an audit trail.
Can I run both investigator and central review?
Yes, as separate records with an assessed-by field, so each assessment has its own date and values. The workflow for sending images to a central reader is outside Capture.
Can biomarker values be locked before randomisation?
Forms move from draft to approved and are locked for live use, and edit checks can enforce valid values. Plan the order of forms so stratification data are final before allocation.
How are subsequent therapies and survival status captured?
Through a short follow-up form with last contact date, status and therapy fields, which can be completed by phone contacts after progression.
Does it work for a single-arm phase 2 study?
Yes. Single-arm designs rely on objective response and duration of response, which use the same assessment form. Capture suits Phase 1 to 3.
Can I get SDTM datasets?
Yes. Capture exports CDISC SDTM as SAS XPT files with Define-XML, alongside CSV and Excel with an automatic data dictionary.
How much does it cost?
The sandbox is free with nearly every feature, no credit card. Plans and prices are on the pricing page.
Keep exploring
Related pages
EDC for oncology trials
The cross-tumour overview.
ePRO for oncology trials
Symptom and quality-of-life capture.
Oncology side effect diary
Between-visit symptom diary.
ECOG performance status template
Performance status at each visit.
Survival sample size calculator
Plan event counts.
CTCAE grade lookup
Grade adverse events consistently.
Pricing
Free sandbox.
Start your NSCLC study free
Free sandbox with nearly every feature. No credit card.